Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT00424294
Status:
TERMINATED
Last Update Posted:
2014-09-25
First Post:
2007-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early because it was determined that the dual therapy with CP-195543 and celecoxib had poor tolerability and a high discontinuation rate.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. All causality treatment-emergent SAEs and Other AEs were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.', 'otherNumAtRisk': 35, 'otherNumAffected': 29, 'seriousNumAtRisk': 35, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.', 'otherNumAtRisk': 34, 'otherNumAffected': 31, 'seriousNumAtRisk': 34, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nodule on extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.43', 'groupId': 'OG000'}, {'value': '35.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.733', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'ACR20 response: greater than or equal to (\\>=) 20 percent (%) improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using last observation carried forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '31.43', 'groupId': 'OG000'}, {'value': '23.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '28.57', 'groupId': 'OG000'}, {'value': '35.29', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '28.57', 'groupId': 'OG000'}, {'value': '41.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '25.71', 'groupId': 'OG000'}, {'value': '38.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.463', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: p-value was calculated by Chi-square test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.549', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: p-value was calculated by Chi-square test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.272', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: p-value was calculated by Chi-square test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.265', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: p-value was calculated by Chi-square test.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, 2, 4, 8', 'description': 'ACR20 response: \\>=20% improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '8.57', 'groupId': 'OG000'}, {'value': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '5.71', 'groupId': 'OG000'}, {'value': '11.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '8.57', 'groupId': 'OG000'}, {'value': '14.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.939', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: p-value was calculated by Fisher exact test.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.323', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: p-value was calculated by Fisher exact test.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.338', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: p-value was calculated by Fisher exact test.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, 2, 4, 8, 12', 'description': 'ACR50 response: \\>=50% improvement in tender joint count; \\>=50% improvement in swollen joint count; and \\>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000'}, {'value': '2.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.746', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: p-value was calculated by Fisher exact test.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, 2, 4, 8, 12', 'description': 'ACR70 response: \\>=70% improvement in tender joint count; \\>=70% improvement in swollen joint count; and \\>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=35, 34)', 'categories': [{'measurements': [{'value': '15.54', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '13.74', 'spread': '7.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=33, 31)', 'categories': [{'measurements': [{'value': '-4.45', 'spread': '5.15', 'groupId': 'OG000'}, {'value': '-4.68', 'spread': '6.29', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=34, 31)', 'categories': [{'measurements': [{'value': '-3.82', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '-6.13', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=31, 25)', 'categories': [{'measurements': [{'value': '-5.68', 'spread': '6.48', 'groupId': 'OG000'}, {'value': '-5.04', 'spread': '6.09', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=33, 24)', 'categories': [{'measurements': [{'value': '-5.15', 'spread': '6.46', 'groupId': 'OG000'}, {'value': '-6.00', 'spread': '7.68', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=30, 21)', 'categories': [{'measurements': [{'value': '-5.67', 'spread': '5.86', 'groupId': 'OG000'}, {'value': '-5.95', 'spread': '9.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.635', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: Analysis of covariance (ANCOVA) with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.957', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.597', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.960', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.', 'unitOfMeasure': 'tender/painful joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=35, 34)', 'categories': [{'measurements': [{'value': '11.49', 'spread': '4.85', 'groupId': 'OG000'}, {'value': '12.00', 'spread': '5.75', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=33, 31)', 'categories': [{'measurements': [{'value': '-3.18', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '-4.35', 'spread': '4.41', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=34, 31)', 'categories': [{'measurements': [{'value': '-2.74', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '-5.97', 'spread': '5.27', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=31, 25)', 'categories': [{'measurements': [{'value': '-3.45', 'spread': '6.20', 'groupId': 'OG000'}, {'value': '-6.32', 'spread': '4.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=33, 24)', 'categories': [{'measurements': [{'value': '-2.79', 'spread': '6.38', 'groupId': 'OG000'}, {'value': '-6.71', 'spread': '5.44', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=30, 21)', 'categories': [{'measurements': [{'value': '-3.80', 'spread': '6.70', 'groupId': 'OG000'}, {'value': '-6.38', 'spread': '6.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.252', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.170', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.', 'unitOfMeasure': 'swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=35, 34)', 'categories': [{'measurements': [{'value': '50.94', 'spread': '23.36', 'groupId': 'OG000'}, {'value': '54.74', 'spread': '22.25', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=33, 30)', 'categories': [{'measurements': [{'value': '-13.27', 'spread': '20.21', 'groupId': 'OG000'}, {'value': '-11.33', 'spread': '15.97', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=34, 32)', 'categories': [{'measurements': [{'value': '-9.53', 'spread': '23.98', 'groupId': 'OG000'}, {'value': '-9.50', 'spread': '23.65', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=31, 25)', 'categories': [{'measurements': [{'value': '-8.16', 'spread': '23.62', 'groupId': 'OG000'}, {'value': '-14.12', 'spread': '24.97', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=33, 24)', 'categories': [{'measurements': [{'value': '-14.06', 'spread': '24.82', 'groupId': 'OG000'}, {'value': '-12.04', 'spread': '29.37', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=30, 21)', 'categories': [{'measurements': [{'value': '-11.50', 'spread': '22.90', 'groupId': 'OG000'}, {'value': '-21.43', 'spread': '35.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.507', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.743', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.914', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.715', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.558', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': "Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=35, 34)', 'categories': [{'measurements': [{'value': '3.14', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=33, 31)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=34, 31)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=31, 25)', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=33, 24)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=30, 21)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.172', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.738', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.948', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.428', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.861', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': "Patient's global assessment of arthritic condition assessed all the ways participants' illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=35, 34)', 'categories': [{'measurements': [{'value': '3.37', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=33, 31)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=34, 31)', 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=31, 25)', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=33, 24)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=30, 21)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.386', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.532', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.909', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.994', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=34, 34)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=32, 30)', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=31, 29)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=30, 25)', 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=32, 24)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=29, 20)', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.369', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.666', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.530', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.632', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.801', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, where 0 = least difficulty and 3 = extreme difficulty.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=34, 34)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=32, 31)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '2.05', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=29, 25)', 'categories': [{'measurements': [{'value': '0.67', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=32, 24)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=29, 21)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.052', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.573', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.342', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.501', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=34, 34)', 'categories': [{'measurements': [{'value': '4.78', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '4.68', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=32, 31)', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=32, 31)', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=29, 25)', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=32, 24)', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=29, 21)', 'categories': [{'measurements': [{'value': '-0.98', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.701', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.167', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.948', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.834', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.977', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 \\* (\\[0.56 \\* square root of TJC\\] + \\[0.28 \\* square root of SJC\\] + \\[0.36 \\* natural logarithm of {CRP+1}\\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \\<= 3.2 implied low disease activity and \\>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \\<2.6 = remission.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=35, 34)', 'categories': [{'measurements': [{'value': '2.83', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '3.22', 'spread': '4.34', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=33, 31)', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=34, 31)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '4.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=31, 25)', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '4.53', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8 (n=33, 24)', 'categories': [{'measurements': [{'value': '0.34', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '5.09', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=30, 21)', 'categories': [{'measurements': [{'value': '1.05', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '5.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.291', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.080', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.466', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.267', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,"n" signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Withdrew From Study Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 12', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Withdrawal Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'timeFrame': 'Baseline up to Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'Median time and corresponding confidence interval (CI) were not estimable because only less than half of the participants withdrew from study due to lack of efficacy and hence, were insufficient for the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adverse Events by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': "An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.", 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 13', 'description': 'Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick \\[urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin\\], microscopy \\[urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous \\[urine mucus and leucocytes\\]).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline: SBP (n=35, 34)', 'categories': [{'measurements': [{'value': '123.7', 'spread': '12.33', 'groupId': 'OG000'}, {'value': '124.6', 'spread': '14.97', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 7: SBP (n=33, 30)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '12.46', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '12.91', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14: SBP (n=1, 5)', 'categories': [{'measurements': [{'value': '5.0', 'spread': 'NA', 'comment': 'Standard Deviation (SD) was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '4.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 21: SBP (n=0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.', 'groupId': 'OG000'}, {'value': '0.0', 'spread': 'NA', 'comment': 'SD was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28: SBP (n=1, 2)', 'categories': [{'measurements': [{'value': '18.0', 'spread': 'NA', 'comment': 'SD was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 42: SBP (n=4, 2)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '28.28', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56: SBP (n=0, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '8.00', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 84: SBP (n=27, 17)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '13.44', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '15.58', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 91: SBP (n=3, 3)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '13.65', 'groupId': 'OG000'}, {'value': '-15.7', 'spread': '12.58', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: DBP (n=35, 34)', 'categories': [{'measurements': [{'value': '77.9', 'spread': '8.03', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '10.81', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 7: DBP (n=33, 30)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '10.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14: DBP (n=1, 5)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'SD was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '7.16', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 21: DBP (n=0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.', 'groupId': 'OG000'}, {'value': '16.0', 'spread': 'NA', 'comment': 'SD was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28: DBP (n=1, 2)', 'categories': [{'measurements': [{'value': '-4.0', 'spread': 'NA', 'comment': 'SD was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '16.97', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 42: DBP (n=4, 2)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '11.31', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56: DBP (n=0, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '7.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 84: DBP (n=27, 17)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '12.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 91: DBP (n=3, 3)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '4.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91', 'description': 'Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, "n" signifies those participants who were evaluable at specified time point for each arm, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Baseline (n=35, 34)', 'categories': [{'measurements': [{'value': '74.3', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '10.62', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 7 (n=33, 30)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '10.00', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '9.70', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 14 (n=5, 1)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': 'SD was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 21 (n=0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.', 'groupId': 'OG000'}, {'value': '2.0', 'spread': 'NA', 'comment': 'SD was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=1, 2)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': 'NA', 'comment': 'SD was not calculable as only 1 participant was evaluable at this time point.', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '8.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 42 (n=4, 2)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '4.24', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 56 (n=0, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as there was no participant evaluable for this arm group at the specified time point.', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '3.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 84 (n=27, 17)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '14.19', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 91 (n=3, 3)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '7.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, "n" signifies those participants who were evaluable at specified time point for each arm, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Abnormal Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'Maximum QTc Interval (msec)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': "Maximum QTcB Interval (Bazett's Correction)", 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': "Maximum QTcF Interval (Fridericia's Correction)", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'QTcF interval 30 to <60 msec Increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'QTcF interval >=60 msec Increase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 12', 'description': "Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and \\>=60 msec.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Categorical Vital Signs Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'OG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'classes': [{'title': 'SBP: >=30 mmHg Increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'DBP: >=30 mmHg Increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Detailed categorical data was not estimated since summarized continuous data of the vital signs were considered sufficient for the analysis as per investigator's discretion."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'FG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo and Celecoxib', 'description': 'Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (\\>=) 10 milligram per week (mg/week) and less than or equal to (\\<=) 25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'BG001', 'title': 'CP-195543 and Celecoxib', 'description': 'CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate \\>=10 mg/week and \\<=25 mg/week via oral or parenteral route was continued as background therapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'See Detailed Description field', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'dispFirstSubmitDate': '2009-04-06', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-10', 'studyFirstSubmitDate': '2007-01-18', 'dispFirstSubmitQcDate': '2011-03-24', 'resultsFirstSubmitDate': '2014-09-10', 'studyFirstSubmitQcDate': '2007-01-18', 'dispFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-10', 'studyFirstPostDateStruct': {'date': '2007-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Adverse Events by Severity', 'timeFrame': 'Baseline up to 28 days after last dose', 'description': "An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function."}, {'measure': 'Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91', 'timeFrame': 'Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91', 'description': 'Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.'}, {'measure': 'Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91', 'timeFrame': 'Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91'}, {'measure': 'Number of Participants With Abnormal Electrocardiogram (ECG)', 'timeFrame': 'Baseline up to Week 12', 'description': "Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and \\>=60 msec."}, {'measure': 'Number of Participants With Categorical Vital Signs Data', 'timeFrame': 'Baseline, Week 12', 'description': 'Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12', 'timeFrame': 'Week 12', 'description': 'ACR20 response: greater than or equal to (\\>=) 20 percent (%) improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8', 'timeFrame': 'Week 1, 2, 4, 8', 'description': 'ACR20 response: \\>=20% improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response', 'timeFrame': 'Week 1, 2, 4, 8, 12', 'description': 'ACR50 response: \\>=50% improvement in tender joint count; \\>=50% improvement in swollen joint count; and \\>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response', 'timeFrame': 'Week 1, 2, 4, 8, 12', 'description': 'ACR70 response: \\>=70% improvement in tender joint count; \\>=70% improvement in swollen joint count; and \\>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).'}, {'measure': 'Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.'}, {'measure': 'Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.'}, {'measure': "Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12", 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': "Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain."}, {'measure': "Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12", 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': "Patient's global assessment of arthritic condition assessed all the ways participants' illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities)."}, {'measure': "Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12", 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, where 0 = least difficulty and 3 = extreme difficulty.'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.'}, {'measure': 'Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 \\* (\\[0.56 \\* square root of TJC\\] + \\[0.28 \\* square root of SJC\\] + \\[0.36 \\* natural logarithm of {CRP+1}\\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \\<= 3.2 implied low disease activity and \\>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \\<2.6 = remission.'}, {'measure': 'Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12', 'timeFrame': 'Baseline, Week 1, 2, 4, 8, 12', 'description': 'Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).'}, {'measure': 'Number of Participants Who Withdrew From Study Due to Lack of Efficacy', 'timeFrame': 'Baseline up to Week 12'}, {'measure': 'Time to Withdrawal Due to Lack of Efficacy', 'timeFrame': 'Baseline up to Week 12'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'Baseline up to Week 13', 'description': 'Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick \\[urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin\\], microscopy \\[urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous \\[urine mucus and leucocytes\\]).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7701005&StudyName=A%20Study%20Of%20CP-195543%20And%20Celecoxib%20Dual%20Therapy%20In%20Subjects%20With%20Rheumatoid%20Arthritis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis', 'detailedDescription': 'Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria\n* Active disease at Screening\n* Stable dose of methotrexate between 10-25 mg/week oral or parenteral\n\nExclusion Criteria:\n\n* A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments\n* A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides'}, 'identificationModule': {'nctId': 'NCT00424294', 'briefTitle': 'A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate', 'orgStudyIdInfo': {'id': 'A7701005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib', 'description': 'Celecoxib with placebo therapy.', 'interventionNames': ['Drug: celecoxib']}, {'type': 'OTHER', 'label': 'Methotrexate', 'description': 'Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'CP-195,543', 'description': 'CP-195,543 and Celecoxib dual therapy.', 'interventionNames': ['Drug: CP-195,543']}], 'interventions': [{'name': 'CP-195,543', 'type': 'DRUG', 'description': 'CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.', 'armGroupLabels': ['CP-195,543']}, {'name': 'celecoxib', 'type': 'DRUG', 'description': 'Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States \\[US\\] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.', 'armGroupLabels': ['Celecoxib']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.', 'armGroupLabels': ['Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 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