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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
Trial details
NCT IDNCT03669367
SponsorFundacion Clinic per a la Recerca Biomédica