Tapered doses of TNFi for Ankylosing Spondylitis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Ankylosing SpondylitisTapered doses of TNFi - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Ankylosing Spondylitis

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Weeks 12, 24, 36, and 48

Baseline and Week 48
Proportion of patients with radiographic progression, defined as an increase in the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) by 2 units
Up to Week 48
Factors predicting flare
Mean quality of life in the tapered-dose arm vs. the standard-dose arm measured using the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire
Proportion of patients experiencing a disease flare by ASDAS or BASDAI
Proportion of patients needing concomitant medication
Proportion of patients with any related severe adverse event
Proportion of patients with functional limitation measured using the Bath Ankylosing Spondylitis Functional Index (BASFI)
Proportion of patients with impaired work productivity and activity measured using the Work Productivity and Activity Impairment Questionnaire for Ankylosing Spondylitis (WPAI:SpA) questionnaire
Week 12
Proportion of patients able to maintain inactive disease or low disease activity, defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 to 2.1 or Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) of <4 on tapered-dose TNFi

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Standard dose of TNFi
1 of 2
Tapered doses of TNFi
1 of 2

Active Control

Experimental Treatment

156 Total Participants · 2 Treatment Groups

Primary Treatment: Tapered doses of TNFi · No Placebo Group · Phase 4

Tapered doses of TNFi
Drug
Experimental Group · 1 Intervention: Tapered doses of TNFi · Intervention Types: Drug
Standard dose of TNFi
Drug
ActiveComparator Group · 1 Intervention: Standard dose of TNFi · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 12, 24, 36, and 48

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,381 Previous Clinical Trials
473,289 Total Patients Enrolled
Robert D. Inman, MDPrincipal InvestigatorUniversity Health Network - Toronto Western Hospital

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are not pregnant.
Adult axSpA patients satisfying the 2009 ASAS Classification Criteria.
You have sustained inactive disease or LDA with an ASDAS of <2.
References