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

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Treatments: Abatacept

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.