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

Phase 1

• Conditions: PALINDROMIC RHEUMATISM; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-004543-20-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 98

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 98
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: frequency and intensity of joint attacks. Adverse events and Effects on ACPA titres;Primary end point(s): Achievement of classification criteria of rheumatoid arthritis (EULAR/ACR 2010) at any time during the follow-up (up to 24 months).;Timepoint(s) of evaluation of this end point: At any time during the follow-up (up to 24 months)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): -Number and intensity of joint attacks.<br> -Adverse Events.<br> -Effects on ACPA serum and anti-CarP antibodies.<br> ;Timepoint(s) of evaluation of this end point: At any time during the follow-up (up to 24 months)