EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)

Phase 4

Completed

• Conditions: Palindromic Rheumatism, Wrist
• Interventions: Drug: Abatacept Injection; Drug: hydroxycloroquina

• Registration Number: NCT03669367
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Study Start: 2019-06-03
• Primary Completion: 2022-06-30
• Status Verified: 2024-07
• Study Completion: 2024-09-30
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
abatacept	Abatacept Injection	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.
hydroxycloroquina	hydroxycloroquina	Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months)

Primary Outcome Measures

Name	Time	Method
The main objective of this trial is to test abatacept efficacy	At any time during the follow-up (up to 24 months)	number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria)

Secondary Outcome Measures

Name	Time	Method
number of participants with titles positives on serum ACPA.(anti-CarP antibodies)	At any time during the follow-up (up to 24 months)	number of participants with titles positives on serum ACPA.(anti-CarP antibodies)
Number of participants with treatment-related adverse events as asesed	At any time during the follow-up (up to 24 months)	Number of participants with treatment-related adverse events as asesed

Trial Locations

Locations (1)

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain