Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-06-21 @ 5:38 PM
Study NCT ID:
NCT03669367
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C538103', 'term': 'Palindromic rheumatism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'National multi-center study, open, controlled and randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2018-09-12', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main objective of this trial is to test abatacept efficacy', 'timeFrame': 'At any time during the follow-up (up to 24 months)', 'description': 'number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as asesed', 'timeFrame': 'At any time during the follow-up (up to 24 months)', 'description': 'Number of participants with treatment-related adverse events as asesed'}, {'measure': 'number of participants with titles positives on serum ACPA.(anti-CarP antibodies)', 'timeFrame': 'At any time during the follow-up (up to 24 months)', 'description': 'number of participants with titles positives on serum ACPA.(anti-CarP antibodies)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Palindromic Rheumatism, Wrist']}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.', 'detailedDescription': 'The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with PR according to Guerne and Weissman modified criteria (18) and with:\n* Disease evolution \\> 3 months and \\< 24 months.\n* ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence).\n* Greater than 18 years of age.\n\nExclusion Criteria:\n\n* Persistent arthritis: (involvement in one or more joints \\> 1 week).\n* Criteria of other rheumatic diseases (RA, SLE, etc.).\n* Evidence of radiographic damage (join erosions).\n* Absence of ACPA or RF.\n* Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).\n* Steroid treatment one month before study entry.\n* Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide, sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs.\n* Pregnant women or who want to be pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT03669367', 'acronym': 'PALABA', 'briefTitle': 'EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)', 'orgStudyIdInfo': {'id': 'PALABA 2017-004543-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'abatacept', 'description': 'abatacept monotherapy (subcutaneous route).: 125 mg solution for injection in pre-filled syringe. In the first year (0-12 months) at a a dose of 125 mg per week (full dose) and in the second year (12-24 months) at a dose of 125 mg every other week (q2w) (optimized dose) injection) - 125 mg x week - subcutaneous use.', 'interventionNames': ['Drug: Abatacept Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hydroxycloroquina', 'description': 'Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months)', 'interventionNames': ['Drug: hydroxycloroquina']}], 'interventions': [{'name': 'Abatacept Injection', 'type': 'DRUG', 'otherNames': ['ORENCIA'], 'description': 'Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.', 'armGroupLabels': ['abatacept']}, {'name': 'hydroxycloroquina', 'type': 'DRUG', 'description': 'oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)', 'armGroupLabels': ['hydroxycloroquina']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project manager Clinical Trial Unit', 'investigatorFullName': 'Anna Cruceta', 'investigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'}}}}