Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-04-22 @ 5:06 PM
Study NCT ID:
NCT02770794
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2016-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Investigators were masked for ultrasound results'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse', 'timeFrame': '48 week', 'description': 'Area under the ROC curve for total power Doppler score at baseline to predict relapse within 48 weeks after discontinuation of infliximab'}], 'secondaryOutcomes': [{'measure': 'Area under the ROC curve for total gray-scale score to predict relapse', 'timeFrame': '48 week', 'description': 'Area under the ROC curve for total gray-scale score at baseline to predict relapse within 48 weeks after discontinuation of infliximab'}, {'measure': 'Change in van der Heijde modified Sharp score', 'timeFrame': '48 week', 'description': 'Change in van der Heijde modified Sharp score at 48 week'}, {'measure': 'Change in Health Assessment Questionnaire-Disability Index', 'timeFrame': '48 week', 'description': 'Change in Health Assessment Questionnaire-Disability Index at 48 week'}, {'measure': 'Change in EuroQoL 5 dimensions-5L', 'timeFrame': '48 week', 'description': 'Change in EuroQoL 5 dimensions-5L at 48 week'}, {'measure': 'EULAR response criteria based on DAS28 after readministration of infliximab', 'timeFrame': '12 week after relapse', 'description': 'EULAR response criteria based on DAS28 at 12 week after relapse and readministration of infliximab'}, {'measure': 'Number of adverse events as assessed by CTCAE v4.0', 'timeFrame': 'Through study completion, an average of 60 weeks', 'description': 'Number of adverse events as assessed by CTCAE v4.0 through study completion, an average of 60 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '24515410', 'type': 'BACKGROUND', 'citation': 'Iwamoto T, Ikeda K, Hosokawa J, Yamagata M, Tanaka S, Norimoto A, Sanayama Y, Nakagomi D, Takahashi K, Hirose K, Sugiyama T, Sueishi M, Nakajima H. Prediction of relapse after discontinuation of biologic agents by ultrasonographic assessment in patients with rheumatoid arthritis in clinical remission: high predictive values of total gray-scale and power Doppler scores that represent residual synovial inflammation before discontinuation. Arthritis Care Res (Hoboken). 2014 Oct;66(10):1576-81. doi: 10.1002/acr.22303.'}, {'pmid': '20360136', 'type': 'BACKGROUND', 'citation': 'Tanaka Y, Takeuchi T, Mimori T, Saito K, Nawata M, Kameda H, Nojima T, Miyasaka N, Koike T; RRR study investigators. Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis: RRR (remission induction by Remicade in RA) study. Ann Rheum Dis. 2010 Jul;69(7):1286-91. doi: 10.1136/ard.2009.121491. Epub 2010 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter prospective clinical trial investigates the accuracy of ultrasound to predict relapse after discontinuation of infliximab and the efficacy/safety of readministration of infliximab in patients with rheumatoid arthritis in a low disease activity state.', 'detailedDescription': 'The objective of this multicenter prospective clinical trial is to determine whether ultrasound predicts relapse after discontinuation of infliximab more accurately than does clinical index and to investigate the efficacy and safety of restarting infliximab after relapse in patients with rheumatoid arthritis in remission or low disease activity on infliximab treatment. Infliximab is discontinued in all enrolled patients. Patients are followed up for 48 weeks for monitoring relapse. If relapse occurs, patients receive readministration of infliximab and are further followed up for 24 weeks to determine the efficacy and safety of infliximab readministration. Primary endpoint is the difference in area under curve (AUC) of receiver operator characteristics (ROC) analysis between total power Doppler score and Disease Activity Score (DAS) 28 at baseline to predict relapse within 48 weeks after discontinuation of infliximab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years or older\n2. RA patients who fulfill 2010 ACR/EULAR Classification Criteria\n3. Patients who have been treated with infliximab (Remicade) for 26 weeks or longer\n4. DAS28 (CRP) \\< 3.2 at screening\n5. Patients who give written informed consent after receiving sufficient information -\n\nExclusion Criteria:\n\n1. Receiving prednisolone \\> 10 mg/day\n2. Receiving biological or molecular-target anti-rheumatic drug\n3. Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit\n4. Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit\n5. History of infusion reaction to infliximab\n6. Current infection which requires treatment\n7. Current or previous demyelinating disorder\n8. Current congestive heart failure which requires treatment\n9. Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period\n10. Patients whom investigator or co-investigator consider inappropriate for other reasons -'}, 'identificationModule': {'nctId': 'NCT02770794', 'acronym': 'OPTIWIT', 'briefTitle': 'Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Chiba University'}, 'officialTitle': 'Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity', 'orgStudyIdInfo': {'id': '137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All patients', 'description': 'Discontinue infliximab; Receive infliximab when relapse', 'interventionNames': ['Drug: Infliximab']}], 'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'description': 'Discontinue infliximab; receive Infliximab when relapse', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '260-8677', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiba University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Kei Ikeda', 'investigatorAffiliation': 'Chiba University'}}}}