Active — Not RecruitingPhase 3

Spondyloarthritis: Inducing Drug-free Remission by Early TNF-alpha Blockade

Belgium90 participantsStarted 2020-08-24

Plain-language summary

The SPARTACUS study will explore the therapeutic efficacy of 2 different treatment strategies for patients suffering from peripheral Spondyloarthritis (pSpA), classified according to the "Assessment in SpondyloArthritis international Society" (ASAS) classification criteria; it will be set up as a 48-week, prospective, randomized, active-comparator controlled, double-blind, double-dummy, clinical trial with a two-fold clinical 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). * 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). The double-blind phase of the study will compare the 2 treatment strategies with regard to the proportion of patients that achieve a status of (sustained) clinical remission. Differences between patients with very early disease (\<3 months symptom duration) versus those with symptom duration between 3 and 12 months, will be evaluated. In patients that reach sustained clinical remission, all study treatments (both in the "csDMARD Step-up"-group and the "TNFi Induction"-group) will be stopped, and long-term, clinical follow-up of these patients will allow to explore the possibility of "drug-free remission"; also with regard to this objective, the difference in symptom duration will be evaluated.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: SPARTACUS Phase A: "Remission-Induction Phase" A subject will be eligible for study participation if all of the following criteria are met: * Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol. * 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 of the following SpA features: * Anterior uveitis confirmed by an ophthalmologist (past or present) * Crohn's disease or ulcerative colitis diagnosed by a gastroenterologist (past or present). * Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or cervicitis 1 month before arthritis). * Psoriasis diagnosed by a dermatologist (past or present). * HLA B27 positivity * Sacroiliitis by imaging defined as bilateral grade 2-4 or unilateral grade 3-4 sacroiliitis on plain radiographs, according to the modified New York criteria or active sacroiliitis on MRI according to the ASAS consensus definition (ref of addendum). * Subjects must have had onset of peripheral SpA symptoms ≤12 months prior to th…

What they're measuring

Clinical remission

Timeframe: 24 weeks

Trial details

NCT IDNCT04435288

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31