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

Fundacion Clinic per a la Recerca Biomédica70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Palindromic Rheumatism, Wrist

Interventions

Abatacept InjectionDRUG

Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.

hydroxycloroquinaDRUG

oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

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)

Time frame: At any time during the follow-up (up to 24 months)

Secondary Outcomes

Number of participants with treatment-related adverse events as asesed

Time frame: At any time during the follow-up (up to 24 months)

number of participants with titles positives on serum ACPA.(anti-CarP antibodies)

Time frame: At any time during the follow-up (up to 24 months)

Data from ClinicalTrials.gov

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