Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation (GO-GUT)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    147
  • sponsor
    University Ghent
Updated on 3 February 2022
remission
tumor necrosis factor
back pain
golimumab
hla-b27
factor a

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 therapy and a shorter time to relapse after stopping anti-tumor necrosis factor 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.

Details
Condition Axial Spondyloarthritis
Treatment Golimumab
Clinical Study IdentifierNCT03270501
SponsorUniversity Ghent
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

Full anti-inflammatory dose of NSAIDs for more than 4 weeks for the duration of the axSpA symptoms
Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy
Exposure to disease-modifying drugs (DMARDSs; i.e. methotrexate and sulfasalazine) in the last 3 months before the ileocolonoscopy
Exposure to systemic corticosteroid treatment in the last 14 days before the ileocolonoscopy
Infection(s) requiring treatment with intravenous antibiotics/antivirals/antifungals within 30 days prior to the baseline visit or oral antibiotics/antivirals/antifungals within 14 days prior to the baseline visit
Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab
History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease
History of listeriosis, histoplasmosis, chronic of active hepatitis B infection, hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis
Have a history of, or concurrent, chronic heart failure, including medically controlled, asymptomatic congestive heart failure
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix
Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of study agent
Positive pregnancy test at screening
Female subjects who are breast-feeding or considering becoming pregnant during the study
Female subjects who do not use contraceptives
History of clinically significant drug or alcohol abuse in the last 12 months
Clinically significant abnormal screening laboratory results as evaluated by the investigator
Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of the normal
Subject with diagnosis and current symptoms of fibromyalgia
Any medical or psychological condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this study
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