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Clinical trial

EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)

ID
Name
PALABA 2017-004543-20
Description
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.
Trial arms
Trial start
2019-06-03
Estimated PCD
2022-06-30
Trial end
2024-09-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Abatacept Injection
Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.
Arms:
abatacept
Other names:
ORENCIA
hydroxycloroquina
oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)
Arms:
hydroxycloroquina
Size
70
Primary endpoint
The main objective of this trial is to test abatacept efficacy
At any time during the follow-up (up to 24 months)
Eligibility criteria
Inclusion Criteria: * Patients with PR according to Guerne and Weissman modified criteria (18) and with: * Disease evolution \> 3 months and \< 24 months. * ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence). * Greater than 18 years of age. Exclusion Criteria: * Persistent arthritis: (involvement in one or more joints \> 1 week). * Criteria of other rheumatic diseases (RA, SLE, etc.). * Evidence of radiographic damage (join erosions). * Absence of ACPA or RF. * Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine). * Steroid treatment one month before study entry. * Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide, sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs. * Pregnant women or who want to be pregnant during the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'National multi-center study, open, controlled and randomized', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}
Updated at
2023-07-17

1 organization

2 products

2 indications

Organization
Fundacion Clinic per a la Recerca Biomédica
Product
Abatacept
Indication
Palindromic Rheumatism
Indication
Wrist
Product
hydroxycloroquina