Palindromic Rheumatism, Wrist
Conditions
Brief 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.
Detailed 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.
Interventions
Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.
DRUGhydroxycloroquina
oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
National multi-center study, open, controlled and randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main objective of this trial is to test abatacept efficacy | At any time during the follow-up (up to 24 months) | number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as asesed | At any time during the follow-up (up to 24 months) | Number of participants with treatment-related adverse events as asesed |
| number of participants with titles positives on serum ACPA.(anti-CarP antibodies) | At any time during the follow-up (up to 24 months) | number of participants with titles positives on serum ACPA.(anti-CarP antibodies) |
Countries
Spain
Outcome results
None listed