At a glance
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Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation, an Early Remission Induction Study
In Brief
A Phase 3 clinical trial evaluating Golimumab for Axial Spondyloarthritis. Completed, enrolled 64 participants across 3 sites.
Detailed Summary
The hypothesis of the study is that the presence of (subclinical) gut inflammation at baseline in patients with early active axial spondyloarthritis predisposes to a more severe disease defined as more need to use anti-tumor necrosis factor α therapy and a shorter time to relapse after stopping anti-tumor necrosis factor α therapy after obtaining sustained clinical remission. Overall, the investigators hypothesize that subclinical gut inflammation is an important predictor in therapy response and outcome. These data could provide better insights into the complex interactions between gut and joint inflammation and guide the physicians in the therapeutic approach.
Study Details
Timeline
Interventions
Axial spondyloarthritis patients who don't have a good treatment response on 2 NSAIDs, will be treated with golimumab. After remission, the therapy will be stopped. All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.