NCT05115903

Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 48-week randomized, controlled, open-label, non-inferiority trial of patients with radiographic or non-radiographic axial spondyloarthritis. The study will include 156 patients with inactive disease or low disease activity (LDA) for at least 6 months on a TNFi at the time of randomization. Participants will be randomized using a 1:1 ratio to either the tapered-dose arm or the standard-dose arm of TNFi. Progressive tapering of TNFi according to a predefined protocol will be allowed as long as the patient is able to maintain inactive disease or LDA during the study period. We hypothesize that, in patients with 6 months or more of inactive or low-activity axial spondyloarthritis, tapered-dose TNFi are non-inferior to standard-dose TNFi in sustaining the disease state for at least 1 year.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Tapered doses of TNFi	To be given subcutaneously via a prefilled syringe/autoinjector (etanercept, adalimumab, certolizumab pegol, golimumab) or intravenously via infusion (infliximab) at increasing dose intervals as specified
DRUG	Standard dose of TNFi	To be given subcutaneously via a prefilled syringe/autoinjector (etanercept, adalimumab, certolizumab pegol, golimumab) or intravenously via infusion (infliximab)

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-07-01
• Completion: 2024-08-01
• First posted: 2021-11-10
• Last updated: 2024-01-17

Locations

1 site across 1 country: Canada