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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
Active disease within the prior 12 months (initial presentation or relapse) that at time of active disease required treatment with prednisone >20 mg/day.
Participant age of 18 years or greater.
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

TAPIR Trial 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.Check my eligibility
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.See study design
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.

TAPIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I needed more than 20 mg/day of prednisone for my condition in the last year.
I am 18 years old or older.
I have been diagnosed with GPA and meet at least 2 of the specific criteria.
I am taking between 5 and 20 mg of prednisone daily.
I am taking TMP/SMX for infection prevention or as a maintenance treatment.
I needed high-dose steroids for my condition in the last year.
My condition is currently in remission.
I am 18 years old or older.
I've been on a stable dose of my immunosuppressive medication for the last month and don't plan to change it.
I am on one of the listed medications for maintenance therapy.

TAPIR Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Physician decision to increase glucocorticoids for disease relapse.
Secondary outcome measures
Health-related quality of life survey
Health-related quality of life surveys
Protocol performance at VCRC Centers of Excellence.
+2 more

Awards & Highlights

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.

TAPIR 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
309 Previous Clinical Trials
387,624 Total Patients Enrolled
Rare Diseases Clinical Research NetworkNETWORK
67 Previous Clinical Trials
18,946 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
1,985 Previous Clinical Trials
42,850,483 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more places open for people who want to participate in this experiment?

"The trial, which was first advertised on February 1st 2014 and had its most recent update on October 11th 2022, is recruiting patients according to the information available on clinicaltrials.gov."

Answered by AI

How does the dosage of Prednisone in this trial compare to other research?

"5 mg Prednisone was first used in 2001, at Hulston Cancer Center. Out of the 595 completed trials, many are still active and being conducted out of Toronto and Minnesota."

Answered by AI

How many research participants are being enrolled in this clinical trial?

"The most recent update on clinicaltrials.gov shows that this trial is still looking for patients and has been since it was first posted on February 1st, 2014. 159 people are needed in total, with 6 different hospitals participating."

Answered by AI

What are some conditions that can be healed with a 5 mg dosage of Prednisone?

"A dosage of 5mg of prednisone is most often used to ameliorate thyroiditis. Additionally, it has been found to be an effective course of treatment for ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Is the 5 mg dosage of Prednisone an FDA-sanctioned medication?

"There is some efficacy data and multiple rounds of safety data from Phase 3 trials, so our team rates the 5 mg Prednisone as a 3 on the Power scale."

Answered by AI

Who else is applying?

What site did they apply to?
St. Joseph's Healthcare
What portion of applicants met pre-screening criteria?
Met criteria
~14 spots leftby Feb 2025