Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT00780793
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2008-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2008-10-27', 'studyFirstSubmitQcDate': '2008-10-27', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RA inflammatory activity over 18 months based on repeated DAS28 measures', 'timeFrame': 'over 18 months'}], 'secondaryOutcomes': [{'measure': 'RA inflammatory activity over 18 months estimated by DAS44 repeated measures', 'timeFrame': 'over 18 months'}, {'measure': 'Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) / (EfficacyMaintenance - EfficacySpacing);', 'timeFrame': 'during the study'}, {'measure': 'Relapse rate over 18 months based on Kaplan Meier survival analysis', 'timeFrame': 'over 18 months'}, {'measure': 'Functional impairment based on HAQ index', 'timeFrame': 'during the study'}, {'measure': 'Health-related quality of life on SF-36', 'timeFrame': 'during the study'}, {'measure': 'Utility based on EQ-5D instrument', 'timeFrame': 'during the study'}, {'measure': 'Structural damage progression over 18 months assessed with the van der HEIJDE-modified Sharp score (SHS)', 'timeFrame': 'over 18 months'}, {'measure': 'Determinants of maintained remission or relapse after TNF-blocker injection spacing', 'timeFrame': 'during teh study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'Remission', 'Therapeutic strategy', 'DMARDs', 'Biological agents'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '26103979', 'type': 'DERIVED', 'citation': 'Fautrel B, Pham T, Alfaiate T, Gandjbakhch F, Foltz V, Morel J, Dernis E, Gaudin P, Brocq O, Solau-Gervais E, Berthelot JM, Balblanc JC, Mariette X, Tubach F. Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: results of the multicentre non-inferiority randomised open-label controlled trial (STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study). Ann Rheum Dis. 2016 Jan;75(1):59-67. doi: 10.1136/annrheumdis-2014-206696. Epub 2015 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Remission is nowadays the recommended therapeutic objective in rheumatoid arthritis. Once this objective is achieved thanks to TNF-blockers, the optimal therapeutic strategy remains unclear, either therapeutic maintenance or progressive DMARD tapering (with a non quantified risk of disease flare).\n\nSTRASS is a 2-arm randomized controlled trial aiming to compare these 2 strategies (DMARD maintenance or progressive spacing of TNF-blocker injections) in terms of remission maintenance, relapse risk, safety issues and economic consequences during 18 months.\n\nThe inclusion period is 18 months, between September 2008 and February 2010.', 'detailedDescription': 'Rationale:\n\nClinical remission is the therapeutic objective in rheumatoid arthritis, as recommended by professional practice guidelines. Once this objective is achieved with subcutaneous TNF-blockers, the maintenance of such treatments - highly efficacious but expensive and potentially toxic - is debated. To date, no reliable data are available to estimate the risk - benefice ratio associated with either their maintenance or their tapering.\n\nObjectives:\n\nIn RA patients in remission, the study aims:\n\n1. To compare RA inflammatory activity based on repeated measures of the Disease Activity Score (DAS) depending on 2 therapeutic schemes: (M) maintenance of unchanged TNF-blockers or (S) tapering of TNF-blocker doses by progressive spacing of subcutaneous injections according to a predefined algorithm;\n2. To estimate the cost - effectiveness ratio of TNF-blocker spacing as compared to TNF-blocker maintenance.\n\nInclusion criteria:\n\n* Patients aged 18 or more, diagnosed with RA according to the 1987 ACR classification criteria;\n* RA treated with subcutaneous TNF-blockers (etanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional DMARD;\n* RA in clinical remission, defined as a stable DAS28 ≤ 2.6 for 6 months or more, without any structural damage progression on X-rays (local reading by the treating rheumatologist);\n\nExclusion criteria:\n\n* Treatment with steroids;\n* progressing disease on X-rays during the year preceding the trial;\n* surgery planed in the 18 coming months;\n* pregnancy;\n* on-going neoplastic disease;\n* other auto-immune disorders different from RA;\n* inability to speak or understand French;\n* absence of signed informed consent;\n* absence of medical insurance coverage.\n\nSample size calculation: 250 patients, 125 for each arm.\n\nCenters: 22 inclusion centers in France.\n\nResearch duration: 3 years. Participation duration for each patient: 18 months. Inclusion period duration: 18 months (Sep 2008 - Feb 2010).\n\nMethods:\n\nEquivalence trial, prospective, randomized, controlled versus usual care, patients remaining blinded of the tested hypotheses.\n\nInvestigators assessing disease activity remain blind of the protocol arm. The statistical analysis will be based on a mixed linear model taking into account repeated data.\n\nRandomization:\n\nComputer-assisted randomization (CleanWeb software) by blocks of unequal size, stratified on inclusion centers and TNF-blocker molecule.\n\nPrimary endpoint:\n\nRA inflammatory activity over 18 months estimated by DAS28 repeated measures.\n\nSecondary endpoints:\n\n* RA inflammatory activity over 18 months estimated by DAS44 repeated measures;\n* Cost - Effectiveness ratio calculated as: (CostMaintenance - CostSpacing) / (EfficacyMaintenance - EfficacySpacing);\n* Relapse rate over 18 months based on Kaplan Meier survival analysis;\n* Functional impairment based on HAQ index;\n* Health-related quality of life on SF-36;\n* Utility based on EQ-5D instrument;\n* Structural damage progression over 18 months assessed with the van der HEIJDE-modified Sharp score (SHS);\n* Safety;\n* Determinants of maintained remission or relapse after TNF-blocker injection spacing.\n\nResearch time sheet:\n\nClinical, biological and imaging follow-up is based on guidelines-recommended RA follow-up.\n\nBiological work-ups specifically dedicated to the research represent 80 mL. The others are part of usual care and may be performed in non-hospital laboratories.\n\nExpected results and perspectives:\n\nThe trial aims to test the feasibility and the risk - benefit ratio of a step-down strategy for TNF-blockers in the course of RA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 or more, diagnosed with RA according to the 1987 ACR classification criteria;\n* RA treated with subcutaneous TNF-blockers (étanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional DMARD;\n* RA in clinical remission, defined as a stable DAS28 ≤ 2.6 for 6 months or more, without any structural damage progression on X-rays (local reading by the treating rheumatologist);\n\nExclusion Criteria:\n\n* Treatment with steroids;\n* progressing disease on X-rays during the year preceding the trial;\n* surgery planed in the 18 coming months;\n* pregnancy;\n* on-going neoplastic disease;\n* other auto-immune disorders different from RA;\n* inability to speak or understand French;\n* absence of signed informed consent;\n* absence of medical insurance coverage.'}, 'identificationModule': {'nctId': 'NCT00780793', 'acronym': 'STRASS', 'briefTitle': 'Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity', 'orgStudyIdInfo': {'id': 'AOM 07127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1-M : Maintenance', 'description': 'Usual care', 'interventionNames': ['Drug: DMARD maintenance']}, {'type': 'EXPERIMENTAL', 'label': '2 -S : Spacing of TNF-blocker injections', 'description': 'Spacing of TNF-blocker injections', 'interventionNames': ['Drug: progressive spacing of TNF-blocker injections']}], 'interventions': [{'name': 'progressive spacing of TNF-blocker injections', 'type': 'DRUG', 'otherNames': ['Spacing (S)'], 'description': 'Experimental arm\n\nProgressive spacing of TNF-blocker injections according to the following algorithm :\n\n* if DAS28 ≤ 2.6 at trimestrial assessment: go for step N+1\n* if DAS28 \\> 2.6 and DAS28 change ≤ 0.6: continue at step N\n* if DAS28 \\> 2.6 and DAS28 change \\> 0.6 : return to step N-1 (relapse as defined by the European expert consensus).\n\nStep 0 (inclusion) :\n\n* Adalimumab 40 mg / 14 days\n* Etanercept 50 mg / 7 days\n\nStep 1 :\n\n* Adalimumab 40 mg / 21 days\n* Etanercept 50 mg / 10 days\n\nStep 2 :\n\n* Adalimumab 40 mg / 28 days\n* Etanercept 50 mg / 14 days\n\nStep 3 :\n\n* Adalimumab 40 mg / 42 days\n* Etanercept 50 mg / 21 days\n\nStep 4 :\n\n* TNF-blocker stop', 'armGroupLabels': ['2 -S : Spacing of TNF-blocker injections']}, {'name': 'DMARD maintenance', 'type': 'DRUG', 'description': 'DMARD maintenance', 'armGroupLabels': ['1-M : Maintenance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Service de rhumatologie / Groupe hospitalier Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bruno Fautrel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'French Society of Rheumatology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}