Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-06-14 @ 7:48 PM
Study NCT ID:
NCT01866150
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to the last visit after initiation of first line biologic treatment (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': 'Adverse events data were planned to be collected only for those participants who received rituximab or tocilizumab, as biologic therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) as monotherapy according to NICE guidelines.', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.', 'otherNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ear Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.'}, {'id': 'OG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-9.5', 'ciUpperLimit': '12.0', 'groupDescription': "A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.", 'statisticalMethod': "Pearson's chi-squared", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \\[\\*\\] the square root \\[√\\] of TJC) plus (+) (0.28 \\* √ of SJC) + (0.70 \\* the natural logarithm \\[ln\\] ESR in millimeters per hour \\[mm/h\\]) + (0.014 \\* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \\<2.6.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR at Month 6.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.'}, {'id': 'OG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'title': 'Month 3 (n=113,214)', 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}]}]}, {'title': 'Last visit (n=133,243)', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '13.6', 'groupDescription': "Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.", 'statisticalMethod': "Pearson's chi-squared", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6349', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '13.1', 'groupDescription': "Comparison at last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.", 'statisticalMethod': "Pearson's chi-squared", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 \\* √ of TJC) + (0.28 \\* √ of SJC) + (0.70 \\* ln ESR in mm/h) + (0.014 \\* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \\< 2.6.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.'}, {'id': 'OG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'title': 'Month 3 (n=113,214)', 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000'}, {'value': '41.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=114,191)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '53.4', 'groupId': 'OG001'}]}]}, {'title': 'Last visit (n=133,243)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '67.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-12.1', 'ciUpperLimit': '10.4', 'groupDescription': "Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.", 'statisticalMethod': "Pearson's chi-squared", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5649', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '15.0', 'groupDescription': "Comparison at Month 6. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.", 'statisticalMethod': "Pearson's chi-squared", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.9', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '20.2', 'groupDescription': "Comparison at the last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.", 'statisticalMethod': "Pearson's chi-squared", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6. LDA was defined as a DAS28 score \\<3.2.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.'}, {'id': 'OG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'title': 'Month 3 (n=103,198)', 'categories': [{'measurements': [{'value': '-2.74', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '-2.84', 'spread': '0.089', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=105,180)', 'categories': [{'measurements': [{'value': '-3.00', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '0.089', 'groupId': 'OG001'}]}]}, {'title': 'Last visit (n=115,215)', 'categories': [{'measurements': [{'value': '-3.39', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '-3.54', 'spread': '0.091', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Comparison at Month 3. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2420', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.149', 'groupDescription': 'Comparison at Month 6. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'groupDescription': 'Comparison at the last visit. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Category of DAS28 Score and Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.'}, {'id': 'OG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'title': 'Baseline: <2.6 (n=117,219)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: ≥2.6 to ≤3.2 (n=117,219)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: >3.2 (n=117,219)', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000'}, {'value': '99.1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: >4 (n=117,219)', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}, {'value': '98.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 3: <2.6 (n=117,222)', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 3: ≥2.6 to ≤3.2 (n=117,222)', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 3: >3.2 (n=117,222)', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 3: >4 (n=117,222)', 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000'}, {'value': '32.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 6: <2.6 (n=117,200)', 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '30.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 6: ≥2.6 to ≤3.2 (n=117,200)', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 6: >3.2 (n=117,200)', 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000'}, {'value': '45.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6: >4 (n=117,200)', 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'Last visit: <2.6 (n=136,254)', 'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}, {'title': 'Last visit: ≥2.6 to ≤3.2 (n=136,254)', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}]}]}, {'title': 'Last visit: >3.2 (n=136,254)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '29.9', 'groupId': 'OG001'}]}]}, {'title': 'Last visit: >4 (n=136,254)', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for the endpoint. Here, 'n' signifies number of participants with available data for specifies category."}, {'type': 'SECONDARY', 'title': 'Duration of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.'}, {'id': 'OG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.30', 'spread': '38.227', 'groupId': 'OG000'}, {'value': '48.48', 'spread': '34.619', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0237', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.81', 'ciLowerLimit': '-16.44', 'ciUpperLimit': '-1.18', 'groupDescription': 'Analysis was performed using a general linear model with cohort as a factor.', 'statisticalMethod': 'General Linear Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': 'Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data for duration of treatment.'}, {'type': 'SECONDARY', 'title': 'Average Methotrexate Dose of Participants on Biological Combination Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.12', 'spread': '5.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'unitOfMeasure': 'milligrams per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in biologic combination group from All Participants Entered Analysis Set. Number of participants analyzed=participants with available data for methotrexate dose.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.'}, {'id': 'OG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'title': 'Baseline (n=129,245)', 'categories': [{'measurements': [{'value': '17.1', 'spread': '6.98', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '7.21', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Month 3 (n=106,203)', 'categories': [{'measurements': [{'value': '-12.5', 'spread': '7.72', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '6.95', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Month 6 (n=107,184)', 'categories': [{'measurements': [{'value': '-14.4', 'spread': '6.93', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '7.51', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Last visit (n=114,215)', 'categories': [{'measurements': [{'value': '-14.9', 'spread': '8.18', 'groupId': 'OG000'}, {'value': '-14.3', 'spread': '7.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': 'The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.', 'unitOfMeasure': 'tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biologic Monotherapy', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.'}, {'id': 'OG001', 'title': 'Biologic Combination', 'description': 'Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.'}], 'classes': [{'title': 'Baseline (n=129,246)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '5.64', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Month 3 (n=106,205)', 'categories': [{'measurements': [{'value': '-7.0', 'spread': '5.05', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '5.10', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Month 6 (n=107,185)', 'categories': [{'measurements': [{'value': '-7.7', 'spread': '5.24', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '5.57', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Last Visit (n=114,216)', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '5.73', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '5.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': 'The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.', 'unitOfMeasure': 'swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Population', 'description': 'Retrospective chart review of all participants with rheumatoid arthritis (RA) who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to National Institute for Health and Care Excellence (NICE) guidelines. Biologic combination therapy included biologic drug therapy (any) plus methotrexate (MTX) or biologic plus MTX plus any other and classical disease-modifying antirheumatic drugs (DMARDs).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '450'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '450'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Retrospective data was collected for 450 participants of whom 151 received biologic monotherapy, 289 received biologic combination therapy and 10 could not be categorized. Participant flow and baseline characteristics are presented for overall population and endpoints are presented for individual group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '450', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Population', 'description': 'Retrospective chart review of all participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to NICE guidelines. Biologic combination therapy included biologic drug therapy (any) plus MTX or biologic plus MTX plus any other and classical DMARDs.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '11.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '331', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants entered analysis set: All participants entered in this retrospective chart review were included.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 476}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2013-05-21', 'resultsFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2013-05-27', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-01', 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)', 'timeFrame': 'Month 6', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \\[28 joints\\], swollen joint count (SJC) \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \\[\\*\\] the square root \\[√\\] of TJC) plus (+) (0.28 \\* √ of SJC) + (0.70 \\* the natural logarithm \\[ln\\] ESR in millimeters per hour \\[mm/h\\]) + (0.014 \\* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \\<2.6."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment', 'timeFrame': 'Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 \\* √ of TJC) + (0.28 \\* √ of SJC) + (0.70 \\* ln ESR in mm/h) + (0.014 \\* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \\< 2.6."}, {'measure': 'Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.', 'timeFrame': 'Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6. LDA was defined as a DAS28 score \\<3.2."}, {'measure': 'Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment', 'timeFrame': 'Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6."}, {'measure': 'Percentage of Participants by Category of DAS28 Score and Timepoint', 'timeFrame': 'Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': "The DAS28 score is a measure of the participant's disease activity calculated using the TJC \\[28 joints\\], SJC \\[28 joints\\], participant's global assessment of disease activity \\[visual analog scale: 0=no disease activity to 100=maximum disease activity\\] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \\<2.6."}, {'measure': 'Duration of Treatment', 'timeFrame': 'Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': 'Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.'}, {'measure': 'Average Methotrexate Dose of Participants on Biological Combination Treatment', 'timeFrame': 'Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)'}, {'measure': 'Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.', 'timeFrame': 'Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': 'The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.'}, {'measure': 'Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment', 'timeFrame': 'Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)', 'description': 'The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected from patients who have been on first-line biologic treatment for at least 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with rheumatoid arthritis with an inadequate response to at least 2 DMARD treatments, one of which includes methotrexate, who are being treated with first-line biologic therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Diagnosis of rheumatoid arthritis by a rheumatologist\n* Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines\n\nExclusion Criteria:\n\n* Primary diagnosis of a condition other than rheumatoid arthritis\n* Current treatment with a biologic in combination without methotrexate\n* Prior treatment with an experimental agent for rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT01866150', 'briefTitle': 'A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Rheumatoid Arthritis: A Comparison of the Effectiveness of Biologic Monotreatment and Biologic and Methotrexate (MTX) Combination Treatment', 'orgStudyIdInfo': {'id': 'ML28642'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CM1 7ET', 'city': 'Chelmsford', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'PO6 3LY', 'city': 'Cosham', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.84654, 'lon': -1.06344}}, {'zip': 'DE22 3NE', 'city': 'Derby', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'CM20 1QX', 'city': 'Harlow', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.77655, 'lon': 0.11158}}, {'zip': 'E11 1NR', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE13 6LH', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'BT63 5QQ', 'city': 'Portadown', 'country': 'United Kingdom', 'geoPoint': {'lat': 54.42302, 'lon': -6.44434}}, {'zip': 'ST6 7AG', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'TR1 3LJ', 'city': 'Truro', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'WN6 9EW', 'city': 'Wigan', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}