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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    98
  • sponsor
    Fundacion Clinic per a la Recerca Biomédica
Updated on 19 April 2022

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.

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.

Details
Condition Palindromic Rheumatism, Wrist
Treatment Abatacept Injection, hydroxycloroquina
Clinical Study IdentifierNCT03669367
SponsorFundacion Clinic per a la Recerca Biomédica
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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