Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Current evidence on tapering of tumor necrosis factor inhibitors (TNFi) in axial spondyloarthritis (axSpA) is still hampered by heterogeneity in tapering regimens, selection and performance biases, and lack of data on optimized treatment dosing strategies especially in real-world clinical settings. This study aims to contribute to the ongoing investigation of disease-activity-guided tapering of TNFi in axSpA in the form of a prospective, randomized controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Adalimumab; Antibodies, Monoclonal; Certolizumab Pegol; Etanercept; Golimumab; Infliximab

Criteria

Inclusion Criteria:

• Adult axSpA patients satisfying the 2009 Assessment of SpondyloArthritis International Society (ASAS) Classification Criteria

• Currently enrolled in the SPARCC Program with successful completion of standard data collection protocol in the Spondylitis Clinic of UHN-Toronto Western Hospital

• Have sustained inactive disease or LDA with an ASDAS of <2.1 or BASDAI <4 for at least 6 months

• On a stable dose of a TNFi (infliximab, etanercept, adalimumab, certolizumab pegol, or golimumab)

Exclusion Criteria:

• Adults axSpA patients with active extra-articular manifestations such as inflammatory bowel disease, psoriasis, and/or uveitis

• Have comorbidities that may preclude clinical assessment (i.e. fibromyalgia or other chronic pain syndromes; chronic inflammatory diseases other than axSpA)

• Have diagnosed psychiatric or personality disorders

• Not enrolled in the Spondyloarthritis Research Consortium of Canada (SPARCC) Program