early axial spondyloarthritis (axSpA) in relation to gut inflammation
Conditions
Interventions
Trade Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Ghent University
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To describe and confirm the relationship between subclinical gut inflammation and axSpA. - To evaluate whether there is a higher need of anti-tumor necrosis factor a (anti-TNFa) treatment in axSpA patients with (subclinical) gut inflammation compared to those without.;Secondary Objective: - To describe the clinical response of a treat-to-target principle in early axSpA and explore the possibility of drug-free remission. - To evaluate the relation between the presence of (subclinical) gut inflammation and the therapeutic response to anti-TNFa in patients with axSpA. - To evaluate the relationship between (subclinical) gut inflammation on the one hand and remission induction and relapse on the other hand in patients with axSpA. ;Primary end point(s): Clinical remission;Timepoint(s) of evaluation of this end point: evaluated on 2 consecutive follow-up visits (interval: 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mucosal healing;Timepoint(s) of evaluation of this end point: evaluated by ileocolonoscopy at time of clinical remission | — |
Countries
Belgium
Contacts
Public ContactHealth, Innovation & Research Insti
Ghent University
Outcome results
None listed