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Tumor Necrosis Factor Inhibitor
TNF Inhibitor Dose Reduction for Ankylosing Spondylitis (BIOTAPE Trial)
Phase 4
Waitlist Available
Led By Robert D. Inman, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On a stable dose of a TNFi (infliximab, etanercept, adalimumab, certolizumab pegol, or golimumab)
Adult axSpA patients satisfying the 2009 Assessment of SpondyloArthritis International Society (ASAS) Classification Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12, 24, 36, and 48
Awards & highlights
BIOTAPE Trial Summary
This trialaims to find the best way to reduce use of tumor necrosis factor inhibitors (TNFi) while managing axial spondyloarthritis (axSpA) in real-world settings.
Who is the study for?
Adults with axial spondyloarthritis (axSpA) who have been on a stable dose of TNFi medications and have low disease activity for at least 6 months. Participants must meet the ASAS Classification Criteria, not be pregnant, and should not have active extra-articular manifestations or other chronic inflammatory diseases.Check my eligibility
What is being tested?
The study is testing whether patients with axSpA can reduce their doses of TNF inhibitors (TNFi) without worsening their condition. It's a randomized trial comparing standard dosing to tapered dosing based on disease activity.See study design
What are the potential side effects?
Potential side effects from TNFi treatments include infections, injection site reactions, allergic reactions, heart failure exacerbation, demyelinating disorders like multiple sclerosis, and possible increased cancer risk.
BIOTAPE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a consistent dose of a TNF inhibitor medication.
Select...
I have been diagnosed with axial spondyloarthritis according to the ASAS criteria.
BIOTAPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 12, 24, 36, and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12, 24, 36, and 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
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
+5 moreBIOTAPE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tapered doses of TNFiExperimental Treatment1 Intervention
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
Group II: Standard dose of TNFiActive Control1 Intervention
Stable doses of TNFi according to the approved summary of product characteristics for biologic agents used in axial spondyloarthritis
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,475 Total Patients Enrolled
Robert D. Inman, MDPrincipal InvestigatorUniversity Health Network - Toronto Western Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have chronic conditions like fibromyalgia that could affect my trial participation.I have axSpA with additional conditions like IBD, psoriasis, or uveitis.I am on a consistent dose of a TNF inhibitor medication.My inflammatory disease has been inactive or mild for at least 6 months.I have been diagnosed with axial spondyloarthritis according to the ASAS criteria.You are not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Tapered doses of TNFi
- Group 2: Standard dose of TNFi
Awards:
This trial has 4 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How has the administration of TNFi in decreasing amounts been found to assist patients?
"TNFi is often prescribed in tapering doses to patients suffering from psoriasis, pjia, severe psoriatic arthritis, as well as Crohn's disease."
Answered by AI
Has the FDA sanctioned tapering doses of TNFi?
"The team at Power ranks Tapered doses of TNFi a 3 on the safety scale, which indicates that this particular treatment has been given approval due to its Phase 4 trial results."
Answered by AI
Are there vacancies for enrolment in this research project?
"Affirmative. Clinicaltrials.gov data indicates that this research project, initially posted on December 1st 2021, is currently searching for participants. 156 individuals are expected to join the trial at one medical centre."
Answered by AI
Are there other investigations exploring the implications of graduated application of TNFi?
"Presently, there are 122 different trials researching Tapered doses of TNFi, with 34 in the third phase. Although most studies for this treatment occur in Xi'an, Shaanxi; globally 3012 sites are running clinical trial investigations."
Answered by AI
What is the participant count of this research experiment?
"Affirmative. Clinicaltrials.gov conveys that this experiment is currently recruiting participants, which commenced on December 1st 2021 and was last modified on November 21st 2022. A total of 156 individuals are being sought from a single location."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
University Health Network - Toronto Western Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
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