EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)

Phase 4 Completed 70 enrolled Fundacion Clinic per a la Recerca Biomédica

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2019-06-03
Primary completion: 2022-06-30
Completion: 2024-09-30

Outcome

Met primary endpoint

paper P = 0.010; risk difference 29.4%, 95% confidence interval 8.2 to 50.7), meeting the primary endpoint. PMID 42135532 ↗

Publications

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 Jul;32(7):2610-2618. doi: 10.1038/s41591-026-04395-6. Epub 2026 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	125 mg	Subcutaneous
Comparator	Hydroxychloroquine	Small molecule	5 mg/kg	Oral