Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-20 @ 10:46 PM
Study NCT ID:
NCT02115750
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bfinck@coherus.com', 'phone': '650-649-3529', 'title': 'Barbara K. Finck, MD Chief Medical Officer', 'organization': 'Coherus BioSciences, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)', 'description': 'Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.', 'eventGroups': [{'id': 'EG000', 'title': 'Enbrel-CHS-0214 (Etanercept)', 'description': 'Enbrel 50mg weekly times 24 weeks and CHS-0214 for weeks 25 to 48.\n\nEtanercept: Head-to-head comparison', 'otherNumAtRisk': 320, 'otherNumAffected': 245, 'seriousNumAtRisk': 320, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'CHS-0214-CHS-0214', 'description': 'CHS-0214 50mg weekly times 48 weeks.\n\nCHS-0214', 'otherNumAtRisk': 604, 'otherNumAffected': 241, 'seriousNumAtRisk': 604, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Tract Infection - Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate Aminotransferase Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 34}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumocystis Jirovecii Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pilonidal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervix Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Invasive Ductal Breast Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign Ovarian Tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder Neoplasma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Papillary Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Nerve Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial Bones Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wrist Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alveolitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Obstructive Pulmonary Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Motility Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Creatine Phosphokinase Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometrial Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Age-Related Macular Degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrotic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 604, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'ACR-20 - 20% Improvement According to American College of Rheumatology Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg weekly times 24 weeks.\n\nEtanercept: Head-to-head comparison'}, {'id': 'OG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg weekly times 24 weeks.\n\nCHS-0214'}], 'classes': [{'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-weeks', 'description': "The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg weekly times 24 weeks.\n\nEtanercept: Head-to-head comparison'}, {'id': 'OG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg weekly times 24 weeks.\n\nCHS-0214'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '56.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000'}, {'value': '74.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '77.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12 and 18', 'description': "Subjects were considered an ACR20 responder if, when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC, 20% decrease in TJC, and 20% improvement in 3 of the following 5 measures:\n\n* High sensitivity C-reactive protein (hs-CRP);\n* Health Assessment Questionnaire-Disability Index (HAQ-DI);\n* Subject's global assessment of pain (ie, subject's pain assessment \\[SPA\\]-visual analog scale \\[VAS\\]);\n* Subject's global assessment of disease activity (SGA-VAS); and\n* Physician's global assessment of disease activity (PGA-VAS).\n\nIn these calculations, the percent change from baseline to endpoint was used to determine ACR20. For percentage change calculations, results were rounded to 5 decimal places prior to comparing to the threshold of 20%.For SJCs and TJCs, the assessment of efficacy was based on mean change from baseline (last non-missing value prior to first dose evaluation).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Summary of Change in Tender Joint Count (TJC) by Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg weekly times 24 weeks.\n\nEtanercept: Head-to-head comparison'}, {'id': 'OG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg weekly times 24 weeks.\n\nCHS-0214'}], 'classes': [{'title': 'TJC - Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.4', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '9.89', 'groupId': 'OG001'}]}]}, {'title': 'TJC - Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.8', 'spread': '10.00', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '11.21', 'groupId': 'OG001'}]}]}, {'title': 'TJC - Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.9', 'spread': '10.21', 'groupId': 'OG000'}, {'value': '-14.7', 'spread': '11.05', 'groupId': 'OG001'}]}]}, {'title': 'TJC - Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.4', 'spread': '10.51', 'groupId': 'OG000'}, {'value': '-16.4', 'spread': '11.91', 'groupId': 'OG001'}]}]}, {'title': 'TJC - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.8', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '12.41', 'groupId': 'OG001'}]}]}, {'title': 'TJC - Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '4.49', 'groupId': 'OG001'}]}]}, {'title': 'TJC - Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '6.39', 'groupId': 'OG001'}]}]}, {'title': 'TJC - Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'The average percent improvement from baseline in individual ACR response criteria: TJC (Tender joint count) the 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count. Hip joints can be evaluated for tenderness.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.'}, {'type': 'SECONDARY', 'title': 'Summary of Change in Swollen Joint Count (SJC) by Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg subcutaneously every week for 24 Weeks.\n\nEtanercept: Head-to-head comparison\n\nIn part 2, all subjects received 50mg subcutaneously every week from week 25-48.'}, {'id': 'OG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg subcutaneously every week for 24 Weeks.\n\nPart 2: All subjects received CHS-0214 50mg subcutaneously every week from week 25-48.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.1', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '6.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '-9.5', 'spread': '7.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'spread': '8.09', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '7.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.7', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '-11.1', 'spread': '7.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '7.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'The 66/68 Joint Count evaluates 66 joints for swelling. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.'}, {'type': 'SECONDARY', 'title': 'Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg subcutaneously every week for 24 Weeks.\n\nEtanercept: Head-to-head comparison\n\nIn part 2, all subjects received 50mg subcutaneously every week from week 25-48.'}, {'id': 'OG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg subcutaneously every week for 24 Weeks.\n\nPart 2: All subjects received CHS-0214 50mg subcutaneously every week from week 25-48.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.313', 'spread': '0.414', 'groupId': 'OG000'}, {'value': '-0.266', 'spread': '0.391', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.377', 'spread': '0.477', 'groupId': 'OG000'}, {'value': '-0.401', 'spread': '0.473', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.444', 'spread': '0.497', 'groupId': 'OG000'}, {'value': '-0.466', 'spread': '0.506', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.493', 'spread': '0.532', 'groupId': 'OG000'}, {'value': '-0.529', 'spread': '0.540', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.594', 'spread': '0.609', 'groupId': 'OG000'}, {'value': '-0.614', 'spread': '0.556', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.243', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.233', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.293', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.272', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.279', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.309', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won\'t be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.'}, {'type': 'SECONDARY', 'title': "Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg subcutaneously every week for 24 Weeks.\n\nEtanercept: Head-to-head comparison\n\nIn part 2, all subjects received 50mg subcutaneously every week from week 25-48.'}, {'id': 'OG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg subcutaneously every week for 24 Weeks.\n\nPart 2: All subjects received CHS-0214 50mg subcutaneously every week from week 25-48.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.5', 'spread': '22.68', 'groupId': 'OG000'}, {'value': '-20.2', 'spread': '22.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.4', 'spread': '25.43', 'groupId': 'OG000'}, {'value': '-27.1', 'spread': '22.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.7', 'spread': '25.86', 'groupId': 'OG000'}, {'value': '-29.3', 'spread': '23.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.8', 'spread': '24.89', 'groupId': 'OG000'}, {'value': '-33.3', 'spread': '25.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-38.2', 'spread': '22.44', 'groupId': 'OG000'}, {'value': '-38.1', 'spread': '24.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '14.25', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '12.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '17.16', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '15.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '16.89', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '16.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'The score range for the SPA-VAS is 0-100 millimeters. One total score was reported for each assessment, no subscales exist. A lower score on the left side represents a better outcome (less pain) and the higher score is on the right side representing a worse outcome (more pain).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.'}, {'type': 'SECONDARY', 'title': "Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit", 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg subcutaneously every week for 24 Weeks.\n\nEtanercept: Head-to-head comparison\n\nIn part 2, all subjects received 50mg subcutaneously every week from week 25-48.'}, {'id': 'OG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg subcutaneously every week for 24 Weeks.\n\nPart 2: All subjects received CHS-0214 50mg subcutaneously every week from week 25-48.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.1', 'spread': '19.04', 'groupId': 'OG000'}, {'value': '-24.3', 'spread': '18.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.6', 'spread': '19.76', 'groupId': 'OG000'}, {'value': '-31.7', 'spread': '19.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.5', 'spread': '20.99', 'groupId': 'OG000'}, {'value': '-35.4', 'spread': '19.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-36.3', 'spread': '20.69', 'groupId': 'OG000'}, {'value': '-38.8', 'spread': '19.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-40.5', 'spread': '19.31', 'groupId': 'OG000'}, {'value': '-43.2', 'spread': '17.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '8.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '10.75', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '11.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '13.28', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '11.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'The score range for PGA-VAS is 0-100 millimeters. The patient\'s assessment of disease activity - with the lowest score on the left side representing "none" to the highest score on the right side representing "extremely active".', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg subcutaneously every week for 24 Weeks.\n\nEtanercept: Head-to-head comparison\n\nIn part 2, all subjects received 50mg subcutaneously every week from week 25-48.'}, {'id': 'FG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg subcutaneously every week for 24 Weeks.\n\nPart 2: All subjects received CHS-0214 50mg subcutaneously every week from week 25-48.'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '323'}, {'groupId': 'FG001', 'numSubjects': '324'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '312'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}, {'title': 'Part 2: All Subjects Receive CHS-0214', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '280'}, {'groupId': 'FG001', 'numSubjects': '284'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '272'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enbrel (Etanercept)', 'description': 'Enbrel 50mg weekly times 24 weeks.\n\nEtanercept: Head-to-head comparison'}, {'id': 'BG001', 'title': 'CHS-0214', 'description': 'CHS-0214 50mg weekly times 24 weeks.\n\nCHS-0214'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '565', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '620', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The overall number of participants is inconsistent with participant flow because of baseline characteristics analysis including both populations one and two.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 647}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'dispFirstSubmitDate': '2016-10-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-07', 'studyFirstSubmitDate': '2014-04-14', 'dispFirstSubmitQcDate': '2016-10-07', 'resultsFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2014-04-15', 'dispFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-07', 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR-20 - 20% Improvement According to American College of Rheumatology Criteria', 'timeFrame': '24-weeks', 'description': "The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)"}], 'secondaryOutcomes': [{'measure': 'ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18', 'timeFrame': 'Weeks 4, 8, 12 and 18', 'description': "Subjects were considered an ACR20 responder if, when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC, 20% decrease in TJC, and 20% improvement in 3 of the following 5 measures:\n\n* High sensitivity C-reactive protein (hs-CRP);\n* Health Assessment Questionnaire-Disability Index (HAQ-DI);\n* Subject's global assessment of pain (ie, subject's pain assessment \\[SPA\\]-visual analog scale \\[VAS\\]);\n* Subject's global assessment of disease activity (SGA-VAS); and\n* Physician's global assessment of disease activity (PGA-VAS).\n\nIn these calculations, the percent change from baseline to endpoint was used to determine ACR20. For percentage change calculations, results were rounded to 5 decimal places prior to comparing to the threshold of 20%.For SJCs and TJCs, the assessment of efficacy was based on mean change from baseline (last non-missing value prior to first dose evaluation)."}, {'measure': 'Summary of Change in Tender Joint Count (TJC) by Study Visit', 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'The average percent improvement from baseline in individual ACR response criteria: TJC (Tender joint count) the 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count. Hip joints can be evaluated for tenderness.'}, {'measure': 'Summary of Change in Swollen Joint Count (SJC) by Study Visit', 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'The 66/68 Joint Count evaluates 66 joints for swelling. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count.'}, {'measure': 'Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit', 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won\'t be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.'}, {'measure': "Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit", 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'The score range for the SPA-VAS is 0-100 millimeters. One total score was reported for each assessment, no subscales exist. A lower score on the left side represents a better outcome (less pain) and the higher score is on the right side representing a worse outcome (more pain).'}, {'measure': "Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit", 'timeFrame': 'Weeks 4,8,12,18,24,28,36,48', 'description': 'The score range for PGA-VAS is 0-100 millimeters. The patient\'s assessment of disease activity - with the lowest score on the left side representing "none" to the highest score on the right side representing "extremely active".'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CHS-0214', 'Enbrel', 'RA', 'Biosimilar', 'Etanercept'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.\n\nPt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.\n\nPt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults\n* RA (Rheumatoid Arthritis) diagnosis for 6 months\n* On stable dose of MTX of 8mg to 25mg per week\n* Active disease: greater than 6 tender joints, greater than 6 swollen joints, C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2\n\nExclusion Criteria:\n\n* Use of prednisone greater than 10mg/day\n* Use of greater than one non-steroidal anti-inflammatory drug (NSAID)\n* Use of biologic therapies for any cause\n* Chemistry and hematology values outside protocol specified range\n* Positive QuantiFERON-tuberculosis (TB) Gold Test\n* Evidence of active lung disease on chest x-ray\n* Major systemic infections\n* Presence of significant comorbid conditions\n* Known allergy to latex\n* Women who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT02115750', 'acronym': 'CHS-0214-02', 'briefTitle': 'Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coherus Oncology, Inc.'}, 'officialTitle': 'A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate', 'orgStudyIdInfo': {'id': 'CHS-0214-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enbrel (etanercept)', 'description': 'Enbrel 50mg weekly times 24 weeks.', 'interventionNames': ['Drug: Etanercept']}, {'type': 'EXPERIMENTAL', 'label': 'CHS-0214', 'description': 'CHS-0214 50mg weekly times 24 weeks.', 'interventionNames': ['Drug: CHS-0214']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel', 'European Enbrel'], 'description': 'Head-to-head comparison', 'armGroupLabels': ['Enbrel (etanercept)']}, {'name': 'CHS-0214', 'type': 'DRUG', 'armGroupLabels': ['CHS-0214']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Clinical Studies', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Baptist Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Dream Team Clinical Research', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Medical Research', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '90808', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pro Health Partners', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Hospital of Orange', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Advances', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '94801', 'city': 'Richmond', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - CA', 'geoPoint': {'lat': 37.93576, 'lon': -122.34775}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Med Investigators, Inc', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Troum Medical Associates', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Inland Rheumatology Clinical Trials Inc', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'IMMUNOe International Research Centers', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Hope Clinical Research', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Medical Research, Inc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33708', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Allergy & Rheumatology Associates LLC', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'HealthPoint Medical Group', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Community Research, Inc', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Rheumatology and Bone Research', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Pharmacology Study Group', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Center for Clinical Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Arthritis Center of Nebraska', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Pacific Arthritis Center Medical Group', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Rheumatoid Arthritis Investigational Network', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'DJL Clinical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington LLC', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Low Country Rheumatology', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Arthritis Clinic', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '76015', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Physicians Medical Research Group', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77036', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pioneer Research Solutions Inc', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Arthritis Northwest Rheumatology PLLC', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53217', 'city': 'Glendale', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Rheumatic Disease Center', 'geoPoint': {'lat': 43.13529, 'lon': -87.93564}}, {'zip': '54650', 'city': 'Onalaska', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gundersen Lutheran Medical Center', 'geoPoint': {'lat': 43.88441, 'lon': -91.23514}}, {'zip': '224027', 'city': 'Brest', 'country': 'Belarus', 'facility': 'Brest Regional Clinical Hospital', 'geoPoint': {'lat': 52.10894, 'lon': 23.71749}}, {'zip': '230017', 'city': 'Grodno', 'country': 'Belarus', 'facility': 'Grodno Regional Clinical Hospital', 'geoPoint': {'lat': 53.62865, 'lon': 23.8942}}, {'zip': '246029', 'city': 'Homyel', 'country': 'Belarus', 'facility': 'Gomel Regional Clinical Hospital', 'geoPoint': {'lat': 52.4345, 'lon': 30.9754}}, {'zip': '220013', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'City Clinical Hospital #1 - Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '220116', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'City Clinical Hospital #9 - Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '210037', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Vitebsk Regional Clinical Hospital', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '38434', 'city': 'Grenoble', 'country': 'France', 'facility': 'Hôpital Michallon - CHU de Grenobl', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU Bicetre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': "Centre Hospitalier Regional D'Orleans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin-Saint Vincent de Paul', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Hopital de Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '93077', 'city': 'Bad Abbach', 'country': 'Germany', 'facility': 'Asklepios Klinikum Bad Abbach', 'geoPoint': {'lat': 48.93754, 'lon': 12.04494}}, {'zip': '01069', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Klinische Forschung 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