Efficacy of golimumab in early axial spondyloarthritis (axSpA) in relation to gut inflammation, an early remission induction study (GO GUT).

Phase 1

• Conditions: early axial spondyloarthritis (axSpA) in relation to gut inflammation; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-001728-23-BE
• Lead Sponsor: Ghent University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-12
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

-Subject must have a diagnosis of axSpA and classified according to ASAS criteria.
-Subject is between 18 and 46 years at the screening visit.
-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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 147
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified