A Prospective, Randomized Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

Who is this study for? Patients with axial spondyloarthritis
What treatments are being studied? Tumor necrosis factor inhibitors
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

• Must not be pregnant

Locations
Other Locations
Canada
University Health Network - Toronto Western Hospital
Toronto
Time Frame
Start Date: 2021-12-01
Completion Date: 2024-08-01
Participants
Target number of participants: 15
Treatments
Experimental: Tapered doses of TNFi
Tapering of TNFi through standardized increases in the dosing interval between drug administration. The tapering dose intervals for each TNFi are designed to decrease the dose from baseline by 75% for 12 weeks, 50% for 24 weeks, and 25% for 12 weeks
Active_comparator: Standard dose of TNFi
Stable doses of TNFi according to the approved summary of product characteristics for biologic agents used in axial spondyloarthritis
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov