Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-01 @ 8:23 PM
Study NCT ID:
NCT01432366
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2011-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)
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'}]}}, '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}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year.", 'otherNumAtRisk': 460, 'otherNumAffected': 82, 'seriousNumAtRisk': 460, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Anal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Anal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Infective exacerbation of bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Sinusitis aspergillus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Suture rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Plasma cell myelomas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': "Morton's neuralgia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Menopausal symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Alopecia areata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Bunion operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Cyst removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Ear operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Foot operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Renal artery stent placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Benign salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Endometrial adeocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Aphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Colon operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Osteosynthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Peripheral endarterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Prolapse repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Salivary gland operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Sinus antrostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Stent placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 460, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra v18.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.16', 'upperLimit': '0.06'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': "Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \\[mm/hour\\]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 \\[very well\\] to 100 millimeter (mm) \\[extremely bad\\]). DAS28 less than or equal to (\\<=) 3.2=low DA; greater than (\\>) 3.2 to \\<=5.1=moderate DA; \\>5.1=high DA; \\<2.6=remission.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set (FAS) included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.13', 'upperLimit': '0.07'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': "Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': "Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \\[very well\\] to 100 mm \\[extremely bad\\]). DAS28 \\<=3.2= low DA; \\>3.2 to \\<=5.1= moderate DA; \\>5.1=high DA; \\<2.6=remission.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.13'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': "Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'Month 6 (n=309)', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.16', 'upperLimit': '0.06'}]}]}, {'title': 'Month 12 (n=285)', 'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.03'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': "Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \\[very well\\] to 100 mm \\[extremely bad\\]). DAS28 \\<=3.2= low DA; \\>3.2 to \\<=5.1= moderate DA; \\>5.1=high DA; \\<2.6=remission.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point."}, {'type': 'SECONDARY', 'title': 'Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'Month 6 (n=354)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.11'}]}]}, {'title': 'Month 12 (n=334)', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.16', 'upperLimit': '0.05'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': "Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point."}, {'type': 'SECONDARY', 'title': 'Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'Month 6 (n=296)', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.18'}]}]}, {'title': 'Month 12 (n=277)', 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '0.14'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': "Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \\[very well\\] to 100 mm \\[extremely bad\\]). DAS28 \\<=3.2= low DA; \\>3.2 to \\<=5.1= moderate DA; \\>5.1=high DA; \\<2.6=remission.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point."}, {'type': 'SECONDARY', 'title': 'Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'Month 6 (n=338)', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-0.08', 'upperLimit': '0.13'}]}]}, {'title': 'Month 12 (n=326)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': "Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at each specified time point."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'BMQ1: Necessity (Agree) (n=426)', 'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}]}]}, {'title': 'BMQ1: Necessity (Totally Agree) (n=426)', 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ2: Concern (Agree) (n=422)', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}]}]}, {'title': 'BMQ2: Concern (Totally Agree) (n=422)', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'BMQ3: Necessity (Agree) (n=424)', 'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ3: Necessity (Totally Agree) (n=424)', 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ4: Concern (Agree) (n=424)', 'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000'}]}]}, {'title': 'BMQ4: Concern (Totally Agree) (n=424)', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ5: Necessity (Agree) (n=427)', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ5: Necessity (Totally Agree) (n=427)', 'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ6: Concern (Agree) (n=419)', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ6: Concern (Totally Agree) (n=419)', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ7: Necessity (Agree) (n=426)', 'categories': [{'measurements': [{'value': '50.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ7: Necessity (Totally Agree) (n=426)', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ8: Concern (Agree) (n=426)', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}]}]}, {'title': 'BMQ8: Concern (Totally Agree) (n=426)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ9: Concern (Agree) (n=424)', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}]}]}, {'title': 'BMQ9: Concern (Totally Agree) (n=424)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ10: Necessity (Agree) (n=427)', 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000'}]}]}, {'title': 'BMQ10: Necessity (Totally Agree (n=427)', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ11: Concern (Agree) (n=428)', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ11: Concern (Totally Agree) (n=428)', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "BAS included all participants who were enrolled in the study and seen at baseline. Here 'n' signifies those participants who were evaluable for the given sub-scale items."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'BMQ1: Necessity (Agree)- Month 6 (n=379)', 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ1: Necessity (Agree)- Month 12 (n=363)', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000'}]}]}, {'title': 'BMQ1: Necessity (Totally Agree)- Month 6 (n=379)', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ1: Necessity (Totally Agree)- Month 12 (n=363)', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}]}]}, {'title': 'BMQ2: Concern (Agree)- Month 6 (n=374)', 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000'}]}]}, {'title': 'BMQ2: Concern (Agree)- Month 12 (n=360)', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'BMQ2: Concern (Totally Agree)- Month 6 (n=374)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ2: Concern (Totally Agree)- Month 12 (n=360)', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ3: Necessity (Agree)- Month 6 (n=376)', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ3: Necessity (Agree)- Month 12 (n=363)', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ3: Necessity (Totally Agree)- Month 6 (n=376)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}]}]}, {'title': 'BMQ3: Necessity (Totally Agree)- Month 12 (n=363)', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ4: Concern (Agree)- Month 6 (n=376)', 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000'}]}]}, {'title': 'BMQ4: Concern (Agree)- Month 12 (n=361)', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}]}]}, {'title': 'BMQ4: Concern (Totally Agree)- Month 6 (n=376)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': 'BMQ4: Concern (Totally Agree)- Month 12 (n=361)', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ5: Necessity (Agree)- Month 6 (n=375)', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ5: Necessity (Agree)- Month 12 (n=362)', 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ5: Necessity (Totally Agree)- Month 6 (n=375)', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}]}]}, {'title': 'BMQ5: Necessity (Totally Agree)- Month 12 (n=362)', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000'}]}]}, {'title': 'BMQ6: Concern (Agree)- Month 6 (n=373)', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ6: Concern (Agree)- Month 12 (n=359)', 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ6: Concern (Totally Agree)- Month 6 (n=373)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ6: Concern (Totally Agree)- Month 12 (n=359)', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ7: Necessity (Agree)- Month 6 (n=376)', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ7: Necessity (Agree)- Month 12 (n=361)', 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ7: Necessity (Totally Agree)- Month 6 (n=376)', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ7: Necessity (Totally Agree)- Month 12 (n=361)', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ8: Concern (Agree)- Month 6 (n=373)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ8: Concern (Agree)- Month 12 (n=361)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ8: Concern (Totally Agree)- Month 6 (n=373)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'BMQ8: Concern (Totally Agree)- Month 12 (n=361)', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'BMQ9: Concern (Agree)- Month 6 (n=375)', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ9: Concern (Agree)- Month 12 (n=361)', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ9: Concern (Totally Agree)- Month 6 (n=375)', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'BMQ9: Concern (Totally Agree)- Month 12 (n=361)', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'BMQ10: Necessity (Agree)- Month 6 (n=380)', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ10: Necessity (Agree)- Month 12 (n=363)', 'categories': [{'measurements': [{'value': '44.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ10: Necessity (Totally Agree)- Month 6 (n=380)', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ10: Necessity (Totally Agree)- Month 12 (n=363)', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ11: Concern (Agree)- Month 6 (n=378)', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ11: Concern (Agree)- Month 12 (n=363)', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ11: Concern (Totally Agree)- Month 6 (n=378)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ11: Concern (Totally Agree)- Month 12 (n=363)', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': "BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'BMQ1: Necessity- Baseline (n=343)', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ1: Necessity- Change at Month 12 (n=343)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ2: Concern- Baseline (n=336)', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ2: Concern-Change at Month 12 (n=336)', 'categories': [{'measurements': [{'value': '-7.1', 'groupId': 'OG000'}]}]}, {'title': 'BMQ3: Necessity- Baseline (n=341)', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ3: Necessity-Change at Month 12 (n=341)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ4: Concern- Baseline (n=340)', 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000'}]}]}, {'title': 'BMQ4: Concern-Change at Month 12 (n=340)', 'categories': [{'measurements': [{'value': '-11.7', 'groupId': 'OG000'}]}]}, {'title': 'BMQ5: Necessity- Baseline (n=344)', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}]}]}, {'title': 'BMQ5: Necessity-Change at Month 12 (n=344)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'BMQ6: Concern- Baseline (n=339)', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}]}]}, {'title': 'BMQ6: Concern-Change at Month 12 (n=339)', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'BMQ7: Necessity- Baseline (n=341)', 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000'}]}]}, {'title': 'BMQ7: Necessity-Change at Month 12 (n=341)', 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000'}]}]}, {'title': 'BMQ8: Concern- Baseline (n=342)', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}]}]}, {'title': 'BMQ8: Concern-Change at Month 12 (n=342)', 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000'}]}]}, {'title': 'BMQ9: Concern- Baseline (n=339)', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ9: Concern-Change at Month 12 (n=339)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'BMQ10: Necessity (n=344)- Baseline (n=344)', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ10: Necessity-Change at Month 12 (n=344)', 'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000'}]}]}, {'title': 'BMQ11: Concern- Baseline (n=344)', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000'}]}]}, {'title': 'BMQ11: Concern-Change at Month 12 (n=344)', 'categories': [{'measurements': [{'value': '-5.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12', 'description': "BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items."}, {'type': 'SECONDARY', 'title': 'Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'BMQ-Necessity (n=409)', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.22'}]}]}, {'title': 'BMQ -Concerns (n=400)', 'categories': [{'measurements': [{'value': '-0.18', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '-0.08'}]}]}, {'title': 'BMQ differential (Necessity-Concerns) (n=399)', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.31'}]}]}, {'title': 'BMQ Overuse (n=405)', 'categories': [{'measurements': [{'value': '-0.17', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '-0.1'}]}]}, {'title': 'BMQ Harm (n=408)', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '-0.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.', 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for each specified subscales."}, {'type': 'SECONDARY', 'title': 'Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'BMQ-Necessity: Month 6 (n=366)', 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.28'}]}]}, {'title': 'BMQ-Necessity: Month 12 (n=349)', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.26'}]}]}, {'title': 'BMQ -Concerns: Month 6 (n=359)', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '-0.05'}]}]}, {'title': 'BMQ -Concerns: Month 12 (n=348)', 'categories': [{'measurements': [{'value': '-0.24', 'groupId': 'OG000', 'lowerLimit': '-0.34', 'upperLimit': '-0.14'}]}]}, {'title': 'BMQ (Necessity-Concerns): Month 6 (n=356)', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.31'}]}]}, {'title': 'BMQ (Necessity-Concerns): Month 12 (n=344)', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.37'}]}]}, {'title': 'BMQ Overuse: Month 6 (n=364)', 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-0.23', 'upperLimit': '-0.03'}]}]}, {'title': 'BMQ Overuse: Month 12 (n=349)', 'categories': [{'measurements': [{'value': '-0.15', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '-0.05'}]}]}, {'title': 'BMQ Harm: Month 6 (n=366)', 'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '-0.00'}]}]}, {'title': 'BMQ Harm: Month 12 (n=350)', 'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000', 'lowerLimit': '-0.29', 'upperLimit': '-0.09'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12', 'description': 'BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.', 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable for each specified subscales."}, {'type': 'SECONDARY', 'title': 'Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'Age (n=422)', 'categories': [{'measurements': [{'value': '-0.030', 'groupId': 'OG000', 'lowerLimit': '-0.13', 'upperLimit': '0.07'}]}]}, {'title': 'Height (n=403)', 'categories': [{'measurements': [{'value': '-0.090', 'groupId': 'OG000', 'lowerLimit': '-0.19', 'upperLimit': '0.008'}]}]}, {'title': 'Weight (n=406)', 'categories': [{'measurements': [{'value': '-0.048', 'groupId': 'OG000', 'lowerLimit': '-0.15', 'upperLimit': '0.05'}]}]}, {'title': 'BMI (n=402)', 'categories': [{'measurements': [{'value': '-0.008', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.09'}]}]}, {'title': 'Time since first RA symptoms (n=409)', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.20'}]}]}, {'title': 'Time since first RA diagnosis (n= 422)', 'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.22'}]}]}, {'title': 'Number (No.) of comorbidities (n=422)', 'categories': [{'measurements': [{'value': '0.051', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.15'}]}]}, {'title': 'No. of joint replacement/surgery (n= 422)', 'categories': [{'measurements': [{'value': '0.053', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "Correlation between BMQ necessity score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for the specified characteristics."}, {'type': 'SECONDARY', 'title': 'Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'classes': [{'title': 'Age (n=409)', 'categories': [{'measurements': [{'value': '-0.078', 'groupId': 'OG000', 'lowerLimit': '-0.17', 'upperLimit': '0.02'}]}]}, {'title': 'Height (n=390)', 'categories': [{'measurements': [{'value': '0.057', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.16'}]}]}, {'title': 'Weight (n=393)', 'categories': [{'measurements': [{'value': '-0.052', 'groupId': 'OG000', 'lowerLimit': '-0.15', 'upperLimit': '0.05'}]}]}, {'title': 'BMI (n=389)', 'categories': [{'measurements': [{'value': '-0.098', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.002'}]}]}, {'title': 'Time since first RA symptoms (n=396)', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.16', 'upperLimit': '0.04'}]}]}, {'title': 'Time since first RA diagnosis (n=409)', 'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.17', 'upperLimit': '0.02'}]}]}, {'title': 'No. of comorbidities (n=409)', 'categories': [{'measurements': [{'value': '-0.076', 'groupId': 'OG000', 'lowerLimit': '-0.17', 'upperLimit': '0.02'}]}]}, {'title': 'No. of joint replacement/surgery (n=409)', 'categories': [{'measurements': [{'value': '-0.051', 'groupId': 'OG000', 'lowerLimit': '-0.15', 'upperLimit': '0.05'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "Correlation between BMQ concerns score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for the specified characteristics."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '460'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '392'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}], 'dropWithdraws': [{'type': 'Non-Responder', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawal Due to Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Site Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Investigator Forget to Complete Visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)', 'description': "Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '336', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis set (BAS) included all participants who were enrolled in the study and seen at baseline.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2011-08-18', 'resultsFirstSubmitDate': '2015-12-14', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-14', 'studyFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12', 'timeFrame': 'Month 12', 'description': "Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \\[mm/hour\\]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 \\[very well\\] to 100 millimeter (mm) \\[extremely bad\\]). DAS28 less than or equal to (\\<=) 3.2=low DA; greater than (\\>) 3.2 to \\<=5.1=moderate DA; \\>5.1=high DA; \\<2.6=remission."}], 'secondaryOutcomes': [{'measure': 'Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12', 'timeFrame': 'Month 12', 'description': "Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy."}, {'measure': 'Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12', 'timeFrame': 'Month 12', 'description': "Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \\[very well\\] to 100 mm \\[extremely bad\\]). DAS28 \\<=3.2= low DA; \\>3.2 to \\<=5.1= moderate DA; \\>5.1=high DA; \\<2.6=remission."}, {'measure': 'Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12', 'timeFrame': 'Month 12', 'description': "Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy."}, {'measure': 'Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count', 'timeFrame': 'Month 6, 12', 'description': "Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \\[very well\\] to 100 mm \\[extremely bad\\]). DAS28 \\<=3.2= low DA; \\>3.2 to \\<=5.1= moderate DA; \\>5.1=high DA; \\<2.6=remission."}, {'measure': 'Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety', 'timeFrame': 'Month 6, 12', 'description': "Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy."}, {'measure': 'Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count', 'timeFrame': 'Month 6, 12', 'description': "Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 \\[very well\\] to 100 mm \\[extremely bad\\]). DAS28 \\<=3.2= low DA; \\>3.2 to \\<=5.1= moderate DA; \\>5.1=high DA; \\<2.6=remission."}, {'measure': 'Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety', 'timeFrame': 'Month 6, 12', 'description': "Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy."}, {'measure': 'Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline', 'timeFrame': 'Baseline', 'description': "BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events)."}, {'measure': 'Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12', 'timeFrame': 'Month 6, 12', 'description': "BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events)."}, {'measure': 'Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12', 'timeFrame': 'Baseline, Month 12', 'description': "BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events)."}, {'measure': 'Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline', 'timeFrame': 'Baseline', 'description': 'BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.'}, {'measure': 'Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12', 'timeFrame': 'Month 6, 12', 'description': 'BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.'}, {'measure': 'Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline', 'timeFrame': 'Baseline', 'description': "Correlation between BMQ necessity score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery."}, {'measure': 'Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline', 'timeFrame': 'Baseline', 'description': "Correlation between BMQ concerns score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A1-4746&StudyName=Correlation%20Between%20Beliefs%20About%20Medicine%20and%20Objective%20Measures%20of%20Efficacy%20and%20Safety%20in%20Rheumatoid%20Arthritis%20%28RA%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'It can be assumed that there is a link between what the patient feels and thinks about his medication and objective measures of disease activity and safety.', 'detailedDescription': 'A total of 500 subjects will provide 80% power to test the hypothesis that the absolute value of the correlation between two measures (e.g., BMQ Necessity and DAS28) is ≤ 0.3 (i.e., H0:│r│ ≤ 0.3 ) versus the alternative that it is \\> 0.3 (i.e., H1:│r │ \\> 0.3 ) assuming the absolute value of the true correlation is 0.40. A total of 500 will be enrolled to allow for approximately 5% being lost from analysis due to lack of post baseline data.\n\nThe Pearson method will be used for correlation between the BMQ total score for Necessity and the DAS28 and between the BMQ total score for Concern and DAS28. The Spearman rank method will be used for correlation between the BMQ total scores and Safety. For these latter analyses, subjects will be classified into one of 3 safety categories: (1) No AEs, (2) Non-serious AEs, (3) Serious AEs. 95% confidence intervals for the correlations will be provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'rheumatoid arthritis patients treated with SC anti-TNF capable of completing some questionnaires', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with RA on stable therapy defined as:\n\nEtanercept: 1x50 mg/week or 2x25mg/week for at least 1 consecutive year. Adalimumab: 1x40 mg every other week for at least 1 consecutive year. Oral corticosteroids: stable doses for ≥ 12 weeks before baseline Methotrexate: stable doses for ≥ 12 weeks before baseline Other DMARD's: stable doses for ≥ 12 weeks before baseline\n\nExclusion Criteria:\n\nParticipation in other clinical or observational trials."}, 'identificationModule': {'nctId': 'NCT01432366', 'acronym': 'CONTENT', 'briefTitle': 'Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Subcutaneous Anti-tnf-αlpha In Rheumatoid Arthritis: Analyze The Correlation Between Objective Measures Of Disease Activity And Safety And A Subjective Measure Such As Patient Beliefs About A Medicine', 'orgStudyIdInfo': {'id': '0881A1-4746'}, 'secondaryIdInfos': [{'id': 'B1801047', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid arthritis patients treated with SC anti-TNF', 'interventionNames': ['Other: SC anti-TNF']}], 'interventions': [{'name': 'SC anti-TNF', 'type': 'OTHER', 'description': 'Subcutaneous (SC) anti-TNF', 'armGroupLabels': ['Rheumatoid arthritis patients treated with SC anti-TNF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis St Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}