Status:
COMPLETED
Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation
Lead Sponsor:
University Ghent
Collaborating Sponsors:
Merck Sharp & Dohme LLC
the Flanders Institute for Biotechnology
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18-46 years
Phase:
PHASE3
Brief 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 mor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03270501
Start Date
November 8 2017
End Date
December 14 2023
Last Update
February 11 2025
Active Locations (3)
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1
Imelda Bonheiden
Bonheiden, Antwerpen, Belgium, 2820
2
Ghent University Hospital
Ghent, B - Belgium, Belgium, 9000
3
Reuma Instituut Hasselt
Hasselt, Limburg, Belgium, 3500