A Study Treating Participants With Early Axial Spondyloarthritis (axSpA) Taking an Intense Treatment Approach Versus Routine Treatment

STRIKE - Treating Patients With Early Axial Spondyloarthritis to Target - a 1 Year Randomized Controlled Study Taking an Intense Treatment Approach Versus Routine Treatment

A study comparing a treat-to-target (T2T) intense treatment approach with routine treatment (Standard of Care [SOC]) in reducing disease activity in participants with axial spondyloarthritis (axSpA).

Inclusion Criteria:

• Signed written informed consent before start of study-related assessments or procedures
• Diagnosis of axSpA (either ankylosing spondylitis or non-radiographic axSpA) and fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA
• Participants aged ≥ 18 years
• Disease duration < 5 years
• Participants must have a Baseline disease activity as defined by an ASDAS ≥ 2.1 or a Bath AS Disease Activity Index (BASDAI) ≥ 4
• NSAID-naive or not treated with the maximal recommended NSAID dose during the last 2 weeks prior to the Baseline visit
• Participants must never have failed a NSAID taken at maximal recommended dose for 2 weeks or more.

Exclusion Criteria:

• Contraindications for NSAIDs or tumor necrosis factor (TNF) blocker according to local labeling
• If entering the study on concomitant NSAIDs, participants taking the maximal recommended dose during the last 2 weeks prior to the Baseline Visit or have failed or developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more at any time
• Prior exposure to any anti-TNF therapy; any biologic therapy with a potential therapeutic impact on SpA, or participant has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline visit.