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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
Imelda Bonheiden
Bonheiden, Antwerpen, Belgium
Ghent University Hospital
Ghent, B - Belgium, Belgium
Reuma Instituut Hasselt
Hasselt, Limburg, Belgium
Proportion of Patients Achieving Sustained Clinical Remission
The proportion of patients who completed the trial and achieved Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) \< 1.3 recorded on 2 consecutive visits with at least 12 weeks interval. ASDAS-CRP was measured at every study visit, i.e. baseline, week 2, week 4, week 16, week 28, week 40 and week 52. The study endpoint could earliest be achieved at visit week 28.
Time frame: Upon end of trial for individual patient, between 28 and 52 weeks.
The Proportion of Patients With Healed Lesions of the Intestinal Mucosa
According to the protocol, every patient underwent ileocolonoscopy at baseline to screen for macroscopic and microscopic (histopathologic analysis of endoscopic biopsies) signs of inflammation. If baseline ileocolonoscopy was protocolled as positive, the patient would undergo a second ileocolonoscopic assessment at the timepoint of reaching sustained clinical remission (study endpoint). The outcome measure is the proportion of patients with a negative second ileocolonoscopy.
Time frame: At reaching primary outcome (between week 24 and week 52)
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