Evaluation of the efficacy and safety of bimekizumab (BZK) or adalimumab (ADA) in the treatment of anterior chest wall pain associated with active axial spondyloarthritis refractory to NSAIDs with hypothesis of superiority of bimekizumab. Randomized, open-label, in parallel arms, head to head trial (ThoracSPA)

Condition studied

axial or predominantly axial SpA with or without psoriasis

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary endpoint will be the ASAS40 response (Spondyloarthritis international Society 40% response) at the 6-month visit. ASAS40 indicates a ≥ 40% improvement in 3 of the 4 domains (BASFI, patient global assessment of disease activity, total spine pain and inflammation (Morning stiffness)

Endpoint detail

The endpoint will be the average spontaneous ACW pain (measured on a NS) between baseline and the 6-month visit using repetitive self-evaluations of pain collected every week at different day times (dedicaded digital tool).