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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Palindromic Rheumatism, Wrist

Intervention / Treatment
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* Drug: Abatacept Injection
* Drug: hydroxycloroquina


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: National multi-center study, open, controlled and randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: abatacept<br>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. | Drug: Abatacept Injection<br>* Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.<br>* Other names: ORENCIA;|
| Active Comparator: hydroxycloroquina<br>Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months) | Drug: hydroxycloroquina<br>* oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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