Strategy study in patients with peripheral spondyloarthritis, in which it is investigated whether induction of remission can be achieved more quickly with early treatment with a TNF-alpha blocker, compared to standard treatment, and in which also factors (blood, joint biopsy) that predict these outcome are investigated.
- Conditions
- peripheral spondyloarthritisMedDRA version: 20.0Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2019-004961-42-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 112
-Subjects must be between 18 and 65 years of age.
-Subjects must have been diagnosed with peripheral spondyloarthritis by the treating rheumatologist.
-Subjects must meet the ASAS classification criteria for peripheral spondyloarthritis: subjects must have current arthritis (asymmetric or predominantly in the lower limbs) or current enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or current dactylitis plus at least 1 SpA features
-Subjects must have had onset of peripheral SpA symptoms =12 months prior to the screening visit.
-Subjects must have active disease at screening defined by Patient Global Assessment of Disease Activity Numerical Rating Scale (NRS) = 4 and Patient Global Assessment of Pain NRS = 4. At the baseline visit patients will be clinically evaluated to exclude spontaneous clinical remission.
-In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms must be the predominant symptoms at study entry based on the Investigator’s clinical judgment.
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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
•Medical history of inflammatory arthritis of a different etiology than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, …).
•Prior adequate treatment with methotrexate and/or sulphasalazine.
•Prior exposure to any biologic therapy with a potential therapeutic impact on SpA.
•Treatment with any investigational drug of chemical or biological nature within a minimum of 30 days or 5 half-lives of the drug (whichever is longer) prior to the Baseline Visit.
•Infection(s) requiring treatment with intravenous (iv) anti-infective agents within 30 days prior to the Baseline visit or oral anti-infectives 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 or active Hepatitis B infection, Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB.
•(History of) chronic heart failure, including medically controlled, asymptomatic CHF.
•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 any live virus or bacterial vaccination within 3 months prior to the first administration of study agent; patients who are expected to receive such vaccinations during the trial, or within 3 months after the last administration of study agent.
•Positive serum pregnancy test at screening.
•Female subjects who are breast-feeding.
•Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
•Positive anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of normal.
•Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
•Subject with current symptoms of fibromyalgia that would confound evaluation of the patient.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare a standard step-up approach using conventional synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs), such as methotrexate and/or sulphasalazine (the csDMARD Step-Up”-strategy), with an early remission-induction treatment strategy that immediately introduces biological DMARDs (bDMARDs) as the first step in the treatment algorithm; in this group the Tumor Necrosis Factor inhibitor (TNFi) golimumab will be utilised (the TNFi Induction”-strategy).;Secondary Objective: To define the window of opportunity within which temporary treatment with bDMARDs might be more effective, by stratifying patients according to symptom duration: patients with shorter symptom duration (<3 months) versus those with more longstanding disease (between 3-12 months of symptom duration).;Primary end point(s): proportion of patients achieving clinical remission;Timepoint(s) of evaluation of this end point: week 24
- Secondary Outcome Measures
Name Time Method