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

This is an interventional treatment trial for Axial Spondyloarthritis Read More

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.