Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-04-20 @ 12:59 AM
Study NCT ID:
NCT02699892
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2016-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, '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 end of the study (up to 72 weeks )', 'description': 'Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Rheumatoid Arthritis Participants', 'description': 'Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.', 'otherNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'seriousNumAffected': 11}], 'seriousEvents': [{'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis Participants', 'description': 'Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 24 weeks after first rituximab infusion (Week 24)', 'description': "DAS28 score is a measure of participant's disease activity calculated using tender joint count \\[28 joints\\] (TJC28), swollen joint count \\[28 joints\\] (SJC28), participant's global assessment of disease activity (PGH) \\[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: \\[0.56 multiplied by (\\*) square root (√) of TJC\\] plus (+) \\[0.28\\*√SJC\\]+\\[0.70\\*the natural logarithm (ln) ESR\\]+\\[0.014\\*PGH\\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\\</=) 3.2 indicated low disease activity, score of greater than (\\>) 3.2 to \\</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With European League Against Rheumatism (EULAR) Good Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis Participants', 'description': 'Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.'}], 'classes': [{'title': 'Week 24 (n=112)', 'categories': [{'measurements': [{'value': '21.43', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 (n=81)', 'categories': [{'measurements': [{'value': '16.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 72 (n=59)', 'categories': [{'measurements': [{'value': '18.64', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 24, 48 and 72', 'description': "Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \\[VAS: 0=no disease activity to 100=maximum disease activity\\] and ESR. DAS28 was calculated by following formula: (0.56\\*√TJC)+(0.28\\*√SJC)+(0.70\\*ln ESR)+(0.014\\*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28\\</=3.2; reduction of DAS28 \\>1.2.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rheumatoid Arthritis Participants', 'description': 'Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}]}]}], 'preAssignmentDetails': 'There was no documentation for the reason for discontinuation; hence, in Participant Flow module, for all participants who did not complete the study, the reason is reported as Unspecified.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rheumatoid Arthritis Participants', 'description': 'Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.28', 'spread': '11.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention-to-treat (ITT) population included all participants, who received at least one dose of the drug under observation and had a subsequent post baseline assessment.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-02', 'studyFirstSubmitDate': '2016-02-25', 'resultsFirstSubmitDate': '2016-09-02', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-02', 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion', 'timeFrame': 'Baseline, 24 weeks after first rituximab infusion (Week 24)', 'description': "DAS28 score is a measure of participant's disease activity calculated using tender joint count \\[28 joints\\] (TJC28), swollen joint count \\[28 joints\\] (SJC28), participant's global assessment of disease activity (PGH) \\[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: \\[0.56 multiplied by (\\*) square root (√) of TJC\\] plus (+) \\[0.28\\*√SJC\\]+\\[0.70\\*the natural logarithm (ln) ESR\\]+\\[0.014\\*PGH\\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\\</=) 3.2 indicated low disease activity, score of greater than (\\>) 3.2 to \\</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With European League Against Rheumatism (EULAR) Good Response', 'timeFrame': 'Baseline, Weeks 24, 48 and 72', 'description': "Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \\[VAS: 0=no disease activity to 100=maximum disease activity\\] and ESR. DAS28 was calculated by following formula: (0.56\\*√TJC)+(0.28\\*√SJC)+(0.70\\*ln ESR)+(0.014\\*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28\\</=3.2; reduction of DAS28 \\>1.2."}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This Phase IV post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. Efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). Protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. Rituximab will be administered at the discretion of treating physician according to approved label.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants receiving rituximab no longer than 4 weeks for the treatment of rheumatoid arthritis before the start of study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Participants receiving rituximab no longer than 4 weeks before the start of monitoring\n\nExclusion Criteria:\n\n-Not Applicable'}, 'identificationModule': {'nctId': 'NCT02699892', 'acronym': 'RITAM', 'briefTitle': 'Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'ML21619'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid arthritis participants', 'description': 'Participants who were on rituximab for rheumatoid arthritis and who will continue receiving rituximab treatment (at the discretion of treating physician) according to previous approved indication will be observed for a period of 72 weeks.', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['MabThera'], 'description': 'Rituximab will be administered at the discretion of treating physician according to approved label. Protocol does not specify/enforce the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab.', 'armGroupLabels': ['Rheumatoid arthritis participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '18250', 'city': 'Niška Banja', 'country': 'Serbia', 'geoPoint': {'lat': 43.29507, 'lon': 22.0057}}, {'zip': '21000', 'city': 'Nova Sad', 'country': 'Serbia'}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}