NCT03669367CompletedPhase 4
EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)
EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)
Source: ClinicalTrials.gov · Last updated 26 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 26 Jul 2018
- Start date
- 3 Jun 2019
- Primary completion date
- 30 Jun 2022
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03669367
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 70
- From 3 Jun 2019 to the primary completion date, 30 Jun 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Criteria of other rheumatic diseases (RA, SLE, etc.).
Other
- Persistent arthritis: (involvement in one or more joints \> 1 week).
- Evidence of radiographic damage (join erosions).
- Absence of ACPA or RF.
- Pregnant women or who want to be pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clínic i Provincial de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.