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Corticosteroid

Prednisone Tapering for Wegener's Granulomatosis (TAPIR Trial)

Phase 3
Waitlist Available
Led By Peter A Merkel, MD, MPH
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant age of 18 years or greater.
Disease remission at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing whether it's better to taper off or stop using prednisone, a medication used to treat inflammation.

Who is the study for?
Adults diagnosed with granulomatosis with polyangiitis (GPA) who've had active disease in the past year but are currently in remission can join. They must be taking a stable dose of certain immunosuppressants and have been on prednisone (5-20 mg/day). Those with conditions likely needing prednisone soon, like severe lung diseases or adrenal problems, can't participate.
What is being tested?
The trial is testing if it's better for GPA patients to continue low-dose prednisone (5 mg daily) or stop it entirely. Participants will be randomly assigned to one of these two options for about six months or until an event occurs that requires ending their participation.
What are the potential side effects?
Potential side effects from continuing low-dose prednisone may include weight gain, high blood pressure, mood swings, increased risk of infections, and bone thinning. Stopping prednisone might lead to withdrawal symptoms such as fatigue and joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My condition is currently in remission.
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I have been diagnosed with GPA and meet at least 2 of the specific criteria.
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I needed high-dose steroids for my condition in the last year.
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I am taking between 5 and 20 mg of prednisone daily.
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I needed more than 20 mg/day of prednisone for my condition in the last year.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Health-related quality of life survey
Health-related quality of life surveys
Protocol performance at VCRC Centers of Excellence.
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 5 mg PrednisoneExperimental Treatment1 Intervention
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
Group II: 0 mg PrednisoneExperimental Treatment1 Intervention
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
363 Previous Clinical Trials
412,345 Total Patients Enrolled
Office of Rare Diseases (ORD)NIH
43 Previous Clinical Trials
12,195 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,076 Previous Clinical Trials
42,719,666 Total Patients Enrolled

Media Library

Prednisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT01940094 — Phase 3
Wegener's Granulomatosis Research Study Groups: 5 mg Prednisone, 0 mg Prednisone
Wegener's Granulomatosis Clinical Trial 2023: Prednisone Highlights & Side Effects. Trial Name: NCT01940094 — Phase 3
Prednisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01940094 — Phase 3
~14 spots leftby Nov 2025
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