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

Sponsor
University Ghent
Study ID
NCT03270501
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 46 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 8, 2017
Status verified
Jul 2024
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023

Study Design

Enrollment
64 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Golimumab

Primary Outcome Measure

Proportion of Patients Achieving Sustained Clinical Remission [ Time Frame: Upon end of trial for individual patient, between 28 and 52 weeks. ]

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