Undifferentiated Arthritis Clinical Trial
Official title:
"A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001".
Patient with undifferentiated arthritis and the presence of anti-citruline (anti-CCP)
antibodies are at high risk to develop RA. The presence of anti-CCP is associated with a
higher rate of erosion and a higher risk of progressive and severe RA.
The investigators have demonstrated in the CIERA study that MTX/IFX combination therapy is
superior to MTX alone to reduce MRI signs of synovitis and bone edema and is clinically more
effective.
The immunopathogenesis of undifferentiated arthritis is poorly understood. However, synovial
studies from patients with early arthritis suggest that UA and RA may share common
immunopathogenic mechanisms. One biopsy study of asymptomatic joints in patients with early
arthritis demonstrates synovitis in more than half of the joints samples with prominent T
cell and macrophage infiltration, similar to Rheumatoid Arthritis (RA).
Thus intensive treatment with anti-TNF antibodies (infliximab) may have an impact on
multiple immune mechanisms driving synovitis in undifferentiated arthritis and may influence
the clinical outcome.
Recently, Methotrexate has been demonstrated to improve the course of undifferentiated
arthritis and prevent the development of RA. Short regimen of more intensive therapy with
Infliximab could alter the radiological, immunopathological and clinical outcome.
not necessary ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03466814 -
Study of the Safety of Orencia in Japanese Children and Adolescents With Active Juvenile Arthritis of Unknown Origin
|