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

Ghent University0 sites147 target enrollmentMay 12, 2017

DrugsSimponi

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Ghent University
Enrollment: 147
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 12, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ghent University

Eligibility Criteria

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.