NCT03270501

Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation

Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation, an Early Remission Induction Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 46 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Golimumab	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.

Timeline

• Start date: 2017-11-08
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2017-09-01
• Last updated: 2025-02-11
• Results posted: 2025-02-11

Locations

3 sites across 1 country: Belgium