Biologic Tapering Study of TNF Inhibitors in Axial Spondyloarthritis (BIOTAPE)

University Health Network, Toronto

Status and phase: Active, not recruiting; Phase 4

Conditions: Axial Spondyloarthritis

Treatments: Drug: Tapered doses of TNFi; Drug: Standard dose of TNFi

Study type: Interventional

Funder types: Other

Identifiers

NCT05115903

21-5211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)
• Must not be pregnant

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Tapered doses of TNFi

Experimental group

Description:

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

Treatment:

Drug: Tapered doses of TNFi

Standard dose of TNFi

Active Comparator group

Description:

Stable doses of TNFi according to the approved summary of product characteristics for biologic agents used in axial spondyloarthritis

Treatment:

Drug: Standard dose of TNFi