Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT00741104
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2008-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)
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': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'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': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck, Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'PI agrees not to publish/publicly present any interim results of the Study. PI further agrees to provide 45 days written notice to Sponsor prior to submission for publication/presentation to permit Sponsor to review drafts of any material before publication which report any results arising out of the Study. Sponsor shall have the right to review and comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'RA Patients', 'description': 'Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \\>= the past 12 months.', 'otherNumAtRisk': 363, 'otherNumAffected': 0, 'seriousNumAtRisk': 363, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dosing Interval Between the Infliximab Infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RA Patients', 'description': 'Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \\>= the past 12 months.'}], 'classes': [{'title': '< every 8 weeks', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'every 8 weeks', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}]}]}, {'title': '> every 8 weeks', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from the Remicade Questionnaire at first (and only) study visit', 'description': 'Patients were asked as part of the Remicade questionnaire what dosing interval they were on.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.', 'timeFrame': 'Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.', 'description': 'This is not a prespecified key secondary outcome; therefore, results will not be disclosed', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Adverse Events (AEs)', 'timeFrame': 'Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.', 'description': 'This is not a prespecified key secondary outcome; therefore, results will not be disclosed', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': "Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.", 'timeFrame': 'Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.', 'description': 'This is not a prespecified key secondary outcome; therefore, results will not be disclosed', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Reason for Extending Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RA Patients', 'description': 'Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \\>= the past 12 months.'}], 'classes': [{'title': 'decreased disease activity', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': "doctor's advice", 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'surgery/co-morbidity', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'vacation/stay abroad', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'pregnancy/trying to become pregnant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from the Remicade Questionnaire at first (and only) study visit', 'description': 'Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks.'}, {'type': 'PRIMARY', 'title': 'Patient Response to Increased Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RA Patients', 'description': 'Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \\>= the past 12 months.'}], 'classes': [{'title': 'positive', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'negative', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from the Remicade Questionnaire at first (and only) study visit', 'description': 'Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked "did you notice any difference when your dosing interval was extended?" Those who noticed a difference were asked if their experience was positive or negative.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks. Among the 106 patients who increased dosing interval, 79 noticed a difference. These 79 were analyzed for this measure.'}, {'type': 'PRIMARY', 'title': 'Number of Patients Agreeing to Participate in a Dose Reduction Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RA Patients', 'description': 'Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \\>= the past 12 months.'}], 'classes': [{'title': 'no', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'yes', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from the Remicade Questionnaire at first (and only) study visit', 'description': 'As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of the 363 subjects in the analysis, 361 subjects answered this question.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RA Patients', 'description': 'Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for \\>= the past 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '363'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '363'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Information about patients' doctor visits prior to this study were obtained from the Swedish Rheumatology Register and the South Swedish Arthritis Treatment Group.", 'preAssignmentDetails': 'RA patients in Sweden normally see their doctor every 6 months. Information obtained from these visits are entered into national registries. Data in this study were based on retrospective review of the two visits preceding the study visit and the visit when infliximab was prescribed for the 1st time, as well as the one and only study visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'RA Patients', 'description': 'Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \\>= the past 12 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '89'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '254', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '363', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Change in dosing interval since previous doctor visit', 'classes': [{'title': 'Decreased dosing interval', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}]}]}, {'title': 'Increased dosing interval', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Data unavailable', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Only 264 patients had this information available from the registry databases.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 363}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-02', 'studyFirstSubmitDate': '2008-07-30', 'resultsFirstSubmitDate': '2009-06-11', 'studyFirstSubmitQcDate': '2008-08-22', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-09', 'studyFirstPostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosing Interval Between the Infliximab Infusions', 'timeFrame': 'Measured from the Remicade Questionnaire at first (and only) study visit', 'description': 'Patients were asked as part of the Remicade questionnaire what dosing interval they were on.'}, {'measure': 'Reason for Extending Dosing Interval', 'timeFrame': 'Measured from the Remicade Questionnaire at first (and only) study visit', 'description': 'Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.'}, {'measure': 'Patient Response to Increased Dosing Interval', 'timeFrame': 'Measured from the Remicade Questionnaire at first (and only) study visit', 'description': 'Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked "did you notice any difference when your dosing interval was extended?" Those who noticed a difference were asked if their experience was positive or negative.'}, {'measure': 'Number of Patients Agreeing to Participate in a Dose Reduction Study', 'timeFrame': 'Measured from the Remicade Questionnaire at first (and only) study visit', 'description': 'As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"'}], 'secondaryOutcomes': [{'measure': 'Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.', 'timeFrame': 'Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.', 'description': 'This is not a prespecified key secondary outcome; therefore, results will not be disclosed'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.', 'description': 'This is not a prespecified key secondary outcome; therefore, results will not be disclosed'}, {'measure': "Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.", 'timeFrame': 'Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.', 'description': 'This is not a prespecified key secondary outcome; therefore, results will not be disclosed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '21407184', 'type': 'RESULT', 'citation': 'Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.'}]}, 'descriptionModule': {'briefSummary': 'This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study. Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study. Patients in this study will be described in terms of demographic and disease characteristics.', 'detailedDescription': 'Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are Swedish patients on maintenance therapy for RA with infliximab for \\>= the past 12 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.\n\nExclusion Criteria:\n\n* episodic treatment with infliximab'}, 'identificationModule': {'nctId': 'NCT00741104', 'acronym': 'REQUEST', 'briefTitle': 'A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients', 'orgStudyIdInfo': {'id': 'P05417'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RA patients', 'description': 'Patients on maintenance therapy for RA with infliximab for \\>= the past 12 months.', 'interventionNames': ['Drug: Infliximab']}], 'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'otherNames': ['Remicade', 'SCH 215596'], 'description': 'Treatment of RA with Infliximab according to and under normal routine clinical practice.', 'armGroupLabels': ['RA patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}