Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation

NCT ID: NCT03270501

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-08
• Study Completion Date: 2023-12-14

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 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.

Conditions

Axial Spondyloarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Golimumab

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

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.

Interventions

Golimumab

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.

Intervention Type: DRUG

Other Intervention Names

ileocoloscopy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

the Flanders Institute for Biotechnology

UNKNOWN

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk Elewaut

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Imelda Bonheiden

Bonheiden, Antwerpen, Belgium

Ghent University Hospital

Ghent, B - Belgium, Belgium

Reuma Instituut Hasselt

Hasselt, Limburg, Belgium

Countries

Belgium

References

Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011 Jun 18;377(9783):2127-37. doi: 10.1016/S0140-6736(11)60071-8.

Reference Type: BACKGROUND

PMID: 21684383 (View on PubMed)

Mielants H, Veys EM, Cuvelier C, De Vos M, Botelberghe L. HLA-B27 related arthritis and bowel inflammation. Part 2. Ileocolonoscopy and bowel histology in patients with HLA-B27 related arthritis. J Rheumatol. 1985 Apr;12(2):294-8.

Reference Type: BACKGROUND

PMID: 3875721 (View on PubMed)

Van Praet L, Van den Bosch FE, Jacques P, Carron P, Jans L, Colman R, Glorieus E, Peeters H, Mielants H, De Vos M, Cuvelier C, Elewaut D. Microscopic gut inflammation in axial spondyloarthritis: a multiparametric predictive model. Ann Rheum Dis. 2013 Mar;72(3):414-7. doi: 10.1136/annrheumdis-2012-202135. Epub 2012 Nov 8.

Reference Type: BACKGROUND

PMID: 23139267 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GO-GUT trial

Identifier Type: -

Identifier Source: org_study_id