EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study) (NCT03669367) | Clinical Trial Compass
CompletedPhase 4
EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)
Spain70 participantsStarted 2019-06-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
The main objective of this trial is to test abatacept efficacy
Timeframe: At any time during the follow-up (up to 24 months)