Spondyloarthritis: Inducing Drug-free Remission by Early TNF-alpha Blockade
Status:
Recruiting
Trial end date:
2026-05-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Ghent
Collaborators:
Merck Sharp & Dohme Corp. Vlaams Instituut voor Biotechnologie (VIB); Merck Sharp & Dohme (MSD)