Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abatacept | Experimental | abatacept monotherapy (subcutaneous route).: 125 mg solution for injection in pre-filled syringe. In the first year (0-12 months) at a a dose of 125 mg per week (full dose) and in the second year (12-24 months) at a dose of 125 mg every other week (q2w) (optimized dose) injection) - 125 mg x week - subcutaneous use. |
|
| hydroxycloroquina | Active Comparator | Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept Injection | Drug | Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year. |
| Measure | Description | Time Frame |
|---|---|---|
| The main objective of this trial is to test abatacept efficacy | number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria) | At any time during the follow-up (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as asesed | 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 titles positives on serum ACPA.(anti-CarP antibodies) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42135532 | Derived | Sanmarti R, Perez-Garcia C, de-Toro FJ, Salvador G, Escudero-Contreras A, Cuervo A, Graell E, Reina D, Kanterewicz E, Corominas H, Urionaguena-Onaindia I, Lopez-Lasanta M, Olive A, Sala-Gomez M, Frade-Sosa B, Morla-Novell RM, Polino L, Meraz-Ostiz JA, Oreiro N, Blanco FJ, Perez-Nadales I, Ortega-Castro R, Busquets-Perez N, Gomez-Centeno AD, Camacho O, Rodriguez-Cros JR, Millan-Arciniegas AM, Garcia-Llorente JF, Borrell H, Prior-Espanol A, Castell-Quinones S, Cruceta A, Bonfill E, Domenech-Gomez G, Roca-Fabregas A, Rios J, Tobalina-Maestre L, Gomara MJ, Haro I. Abatacept versus hydroxychloroquine for prevention of rheumatoid arthritis in individuals with palindromic rheumatism: a randomized open-label trial. Nat Med. 2026 May 14. doi: 10.1038/s41591-026-04395-6. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C538103 | Palindromic rheumatism |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
Not provided
Not provided
National multi-center study, open, controlled and randomized
Not provided
Not provided
Not provided
Not provided
|
| hydroxycloroquina | Drug | oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months) |
|
number of participants with titles positives on serum ACPA.(anti-CarP antibodies) |
| At any time during the follow-up (up to 24 months) |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |