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

Who is this study for? Adult patients with Axial Spondyloarthritis
What treatments are being studied? Golimumab
Status: Completed
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 46
Healthy Volunteers: f
View:

• Subject must have a diagnosis of axSpA and classified according to ASAS criteria.

• Subject has at least 3 months and maximum 1 year (almost) daily chronic back pain.

• Subject has an active disease defined as a positive MRI (according to ASAS definition) or elevated CRP (in patients who are HLA-B27+) and an ASDAS score \> 2.1 (at least high disease activity).

Locations
Other Locations
Belgium
Imelda Bonheiden
Bonheiden
Ghent University Hospital
Ghent
Reuma Instituut Hasselt
Hasselt
Time Frame
Start Date: 2017-11-08
Completion Date: 2023-12-14
Participants
Target number of participants: 64
Treatments
Experimental: Arm 1: Golimumab
Sponsors
Collaborators: Merck Sharp & Dohme LLC, the Flanders Institute for Biotechnology
Leads: University Ghent

This content was sourced from clinicaltrials.gov