Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00794118
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2008-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)
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': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months.", 'otherNumAtRisk': 272, 'otherNumAffected': 21, 'seriousNumAtRisk': 272, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 13}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchopulmonary infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood pressure high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (\\<=) 3.2 = low disease activity, DAS28 greater than (\\>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (\\<) 2.6.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \\<2.6.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \\<2.6.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \\< 2.6.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).'}, {'type': 'PRIMARY', 'title': 'Disease Activity Score Based on 28-joints Count (DAS28) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Disease Activity Score Based on 28-joints Count (DAS28) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Disease Activity Score Based on 28-joints Count (DAS28) at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Disease Activity Score Based on 28-joints Count (DAS28) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Patient Global Assessment (PtGA) of Disease Activity Score at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Patient Global Assessment (PtGA) of Disease Activity Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Patient Global Assessment (PtGA) of Disease Activity Score at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Patient Global Assessment (PtGA) of Disease Activity Score at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Physician Global Assessment (PGA) of Disease Activity at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Physician Global Assessment (PGA) of Disease Activity at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Physician Global Assessment (PGA) of Disease Activity at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Physician Global Assessment (PGA) of Disease Activity at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scale for Pain (VAS-pain) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scale for Pain (VAS-pain) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scale for Pain (VAS-pain) at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scale for Pain (VAS-pain) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (CRP) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (CRP) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (CRP) at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (CRP) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Erythrocyte Sedimentation Rate (ESR) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '18.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Erythrocyte Sedimentation Rate (ESR) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'spread': '16.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Erythrocyte Sedimentation Rate (ESR) at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'spread': '13.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Erythrocyte Sedimentation Rate (ESR) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '18.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Rheumatoid Factor (RF) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Rheumatoid Factor (RF) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Rheumatoid Factor (RF) at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Rheumatoid Factor (RF) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-nuclear Antibodies at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-nuclear Antibodies at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-nuclear Antibodies at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-nuclear Antibodies at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Duration of Morning Stiffness at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '26.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Duration of Morning Stiffness at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '19.6', 'spread': '32.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Duration of Morning Stiffness at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '17.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Duration of Morning Stiffness at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '23.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': 'Stanford Health Assessment Questionnaire (HAQ) Score at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Stanford Health Assessment Questionnaire (HAQ) Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Stanford Health Assessment Questionnaire (HAQ) Score at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 9', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Stanford Health Assessment Questionnaire (HAQ) Score at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'PRIMARY', 'title': '36-Item Short-Form Health Survey (SF-36) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'classes': [{'title': 'ISF', 'categories': [{'measurements': [{'value': '52.2', 'spread': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'ISM', 'categories': [{'measurements': [{'value': '55.5', 'spread': '11.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Direct Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'timeFrame': 'Baseline, Months 3, 6, 9 and 12', 'description': 'Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Indirect Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'timeFrame': 'Baseline, Months 3, 6, 9 and 12', 'description': 'Indirect costs represent the loss of resources as a consequence of work disability or unemployment.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Changed hospital center', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Anti-tumor Necrosis Factor (Anti-TNF) Agents', 'description': "Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months."}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 34 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': '35 to 49 years', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}, {'title': '50 to 64 years', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}]}]}, {'title': 'Greater than or equal to (>=) 65 years', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '230', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Percentage of participants with Disease Activity Score Based on 28-joints count (DAS28) remission', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the ESR and PtGA of disease activity. DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \\<2.6.', 'unitOfMeasure': 'Percentage of participants'}, {'title': 'Disease Activity Score Based on 28-joints count (DAS28)', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR and PtGA of disease activity. DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity. Number of participants analyzed (N)=272 for this parameter.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Global Assessment (PtGA)', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '2.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'PtGA measured using a 10 cm Visual Analog Scale (VAS) ranging from 0 cm = very good to 10 cm = very bad.', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physician Global Assessment (PGA)', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Visual Analogue Scale for Pain (VAS-pain)', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '2.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range: 0 cm = no pain to 10 cm = worst possible pain.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'C-reactive Protein (CRP)', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '6.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. Number of participants analyzed (N) = 272 for this parameter.', 'unitOfMeasure': 'milligram/deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Erythrocyte Sedimentation Rate (ESR)', 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '22.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.', 'unitOfMeasure': 'millimeter/hour (mm/hr)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rheumatoid Factor (RF)', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}, {'title': 'Not available (NA)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 unit/milliliter (U/mL) is considered positive.', 'unitOfMeasure': 'Participants'}, {'title': 'Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.", 'unitOfMeasure': 'Participants'}, {'title': 'Anti-nuclear antibodies', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.', 'unitOfMeasure': 'Participants'}, {'title': 'Anti-deoxyribonucleic Acid (Anti-DNA) antibodies', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of morning stiffness', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '48.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stanford Health Assessment Questionnaire (HAQ)', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Average score range: 0 to 3.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '36-Item Short-Form Health Survey (SF-36)', 'classes': [{'title': 'Indice sintetico salute fisica del (ISF)', 'categories': [{'measurements': [{'value': '38.8', 'spread': '10.6', 'groupId': 'BG000'}]}]}, {'title': 'Indice sintetico salute mentale del (ISM)', 'categories': [{'measurements': [{'value': '48.0', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease duration', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'BG000', 'lowerLimit': '2.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Number of tender joints', 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '7.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The mean number of tender joints was evaluated based on the number of tender joints in a standard 28 joint count.', 'unitOfMeasure': 'Tender joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of swollen joints (SJC)', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '5.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 28 joint count.', 'unitOfMeasure': 'Swollen joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percentage of participants given Disease Modifying Anti-Rheumatoid Drugs (DMARD)', 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Percentage of participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-20', 'studyFirstSubmitDate': '2008-11-17', 'resultsFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-04-12', 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3', 'timeFrame': 'Month 3', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (\\<=) 3.2 = low disease activity, DAS28 greater than (\\>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (\\<) 2.6.'}, {'measure': 'Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6', 'timeFrame': 'Month 6', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \\<2.6.'}, {'measure': 'Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9', 'timeFrame': 'Month 9', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \\<2.6.'}, {'measure': 'Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12', 'timeFrame': 'Month 12', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \\< 2.6.'}, {'measure': 'Disease Activity Score Based on 28-joints Count (DAS28) at Month 3', 'timeFrame': 'Month 3', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.'}, {'measure': 'Disease Activity Score Based on 28-joints Count (DAS28) at Month 6', 'timeFrame': 'Month 6', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.'}, {'measure': 'Disease Activity Score Based on 28-joints Count (DAS28) at Month 9', 'timeFrame': 'Month 9', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.'}, {'measure': 'Disease Activity Score Based on 28-joints Count (DAS28) at Month 12', 'timeFrame': 'Month 12', 'description': 'DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \\<=3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.'}, {'measure': 'Patient Global Assessment (PtGA) of Disease Activity Score at Month 3', 'timeFrame': 'Month 3', 'description': 'PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.'}, {'measure': 'Patient Global Assessment (PtGA) of Disease Activity Score at Month 6', 'timeFrame': 'Month 6', 'description': 'PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.'}, {'measure': 'Patient Global Assessment (PtGA) of Disease Activity Score at Month 9', 'timeFrame': 'Month 9', 'description': 'PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.'}, {'measure': 'Patient Global Assessment (PtGA) of Disease Activity Score at Month 12', 'timeFrame': 'Month 12', 'description': 'PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.'}, {'measure': 'Physician Global Assessment (PGA) of Disease Activity at Month 3', 'timeFrame': 'Month 3', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.'}, {'measure': 'Physician Global Assessment (PGA) of Disease Activity at Month 6', 'timeFrame': 'Month 6', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.'}, {'measure': 'Physician Global Assessment (PGA) of Disease Activity at Month 9', 'timeFrame': 'Month 9', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.'}, {'measure': 'Physician Global Assessment (PGA) of Disease Activity at Month 12', 'timeFrame': 'Month 12', 'description': 'PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.'}, {'measure': 'Visual Analogue Scale for Pain (VAS-pain) at Month 3', 'timeFrame': 'Month 3', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.'}, {'measure': 'Visual Analogue Scale for Pain (VAS-pain) at Month 6', 'timeFrame': 'Month 6', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.'}, {'measure': 'Visual Analogue Scale for Pain (VAS-pain) at Month 9', 'timeFrame': 'Month 9', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.'}, {'measure': 'Visual Analogue Scale for Pain (VAS-pain) at Month 12', 'timeFrame': 'Month 12', 'description': '10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.'}, {'measure': 'C-reactive Protein (CRP) at Month 3', 'timeFrame': 'Month 3', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.'}, {'measure': 'C-reactive Protein (CRP) at Month 6', 'timeFrame': 'Month 6', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.'}, {'measure': 'C-reactive Protein (CRP) at Month 9', 'timeFrame': 'Month 9', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.'}, {'measure': 'C-reactive Protein (CRP) at Month 12', 'timeFrame': 'Month 12', 'description': 'CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR) at Month 3', 'timeFrame': 'Month 3', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR) at Month 6', 'timeFrame': 'Month 6', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR) at Month 9', 'timeFrame': 'Month 9', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR) at Month 12', 'timeFrame': 'Month 12', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.'}, {'measure': 'Number of Participants With Rheumatoid Factor (RF) at Month 3', 'timeFrame': 'Month 3', 'description': 'RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.'}, {'measure': 'Number of Participants With Rheumatoid Factor (RF) at Month 6', 'timeFrame': 'Month 6', 'description': 'RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.'}, {'measure': 'Number of Participants With Rheumatoid Factor (RF) at Month 9', 'timeFrame': 'Month 9', 'description': 'RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.'}, {'measure': 'Number of Participants With Rheumatoid Factor (RF) at Month 12', 'timeFrame': 'Month 12', 'description': 'RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.'}, {'measure': 'Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3', 'timeFrame': 'Month 3', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive."}, {'measure': 'Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6', 'timeFrame': 'Month 6', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive."}, {'measure': 'Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9', 'timeFrame': 'Month 9', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive."}, {'measure': 'Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12', 'timeFrame': 'Month 12', 'description': "Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive."}, {'measure': 'Number of Participants With Anti-nuclear Antibodies at Month 3', 'timeFrame': 'Month 3', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.'}, {'measure': 'Number of Participants With Anti-nuclear Antibodies at Month 6', 'timeFrame': 'Month 6', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.'}, {'measure': 'Number of Participants With Anti-nuclear Antibodies at Month 9', 'timeFrame': 'Month 9', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.'}, {'measure': 'Number of Participants With Anti-nuclear Antibodies at Month 12', 'timeFrame': 'Month 12', 'description': 'Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.'}, {'measure': 'Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3', 'timeFrame': 'Month 3', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.'}, {'measure': 'Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6', 'timeFrame': 'Month 6', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.'}, {'measure': 'Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9', 'timeFrame': 'Month 9', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.'}, {'measure': 'Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12', 'timeFrame': 'Month 12', 'description': 'Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.'}, {'measure': 'Duration of Morning Stiffness at Month 3', 'timeFrame': 'Month 3', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.'}, {'measure': 'Duration of Morning Stiffness at Month 6', 'timeFrame': 'Month 6', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.'}, {'measure': 'Duration of Morning Stiffness at Month 9', 'timeFrame': 'Month 9', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.'}, {'measure': 'Duration of Morning Stiffness at Month 12', 'timeFrame': 'Month 12', 'description': 'Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.'}, {'measure': 'Stanford Health Assessment Questionnaire (HAQ) Score at Month 3', 'timeFrame': 'Month 3', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).'}, {'measure': 'Stanford Health Assessment Questionnaire (HAQ) Score at Month 6', 'timeFrame': 'Month 6', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).'}, {'measure': 'Stanford Health Assessment Questionnaire (HAQ) Score at Month 9', 'timeFrame': 'Month 9', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).'}, {'measure': 'Stanford Health Assessment Questionnaire (HAQ) Score at Month 12', 'timeFrame': 'Month 12', 'description': 'HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).'}, {'measure': '36-Item Short-Form Health Survey (SF-36) at Month 12', 'timeFrame': 'Month 12', 'description': 'SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).'}], 'secondaryOutcomes': [{'measure': 'Direct Costs', 'timeFrame': 'Baseline, Months 3, 6, 9 and 12', 'description': 'Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.'}, {'measure': 'Indirect Costs', 'timeFrame': 'Baseline, Months 3, 6, 9 and 12', 'description': 'Indirect costs represent the loss of resources as a consequence of work disability or unemployment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A1-102321&StudyName=Drug%20Outcome%20Survey%20for%20Biological%20Treatments%20in%20Rheumatoid%20Arthritis%3A%20an%20Observational%20Study%20%28Dose%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only from subjects providing informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eighteen years of age or older\n2. Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:\n\n 1. Morning stiffness in and around the joints lasting at least 1 hour;\n 2. Arthritis of 3 or more joint areas;\n 3. Arthritis of hand joints;\n 4. Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;\n 5. Rheumatoid nodules;\n 6. Serum Rheumatoid Factor (RF)\n 7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.\n3. Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology\n4. Patients naive to anti-TNF drugs\n5. Outpatients\n\nExclusion Criteria:\n\nPatients involved in controlled or interventional trials in the 12 previous months'}, 'identificationModule': {'nctId': 'NCT00794118', 'acronym': 'DOSE', 'briefTitle': 'Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study', 'orgStudyIdInfo': {'id': '0881A1-102321'}, 'secondaryIdInfos': [{'id': 'B1801119'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1.0', 'description': 'As per routinary clinical practice', 'interventionNames': ['Other: As per clinical practice']}], 'interventions': [{'name': 'As per clinical practice', 'type': 'OTHER', 'otherNames': ['Observational study'], 'description': 'As per clinical practice', 'armGroupLabels': ['1.0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}