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Corticosteroid

Low-Dose Prednisone for Granulomatosis with Polyangiitis (TAPIR Trial)

Phase 3

Waitlist Available

Led By Jeffrey P Krischer, PhD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

TAPIR Trial Summary

This trial is testing whether it's better to stay on a low dose of steroids or to stop taking them entirely when in remission from Wegener's Granulomatosis.

Who is the study for?

This trial is for adults over 18 with granulomatosis with polyangiitis (GPA), also known as Wegener's Granulomatosis, who are in remission but have had active disease within the last year. They must be on a stable dose of prednisone between 5mg and 20mg per day, with their doctor agreeing that either continuing or stopping prednisone is acceptable care.Check my eligibility

What is being tested?

The TAPIR study compares the effects of continuing low-dose prednisone (5 mg/day) versus stopping it entirely in patients with GPA in remission. It aims to see which approach better prevents disease flares. Participants will manage their treatment online without extra travel.See study design

What are the potential side effects?

Potential side effects from continued use of low-dose prednisone may include weight gain, bone loss, high blood pressure, mood swings, and increased risk of infections. Stopping prednisone might increase the risk of a disease flare.

TAPIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prednisone dose increase for disease relapse

Secondary outcome measures

Health related quality of life

Protocol performance

Rates of disease flare sub types

+2 more

TAPIR Trial Design

2Treatment groups

Experimental Treatment

Group I: 5 mg prednisoneExperimental Treatment1 Intervention

Subjects will be randomized to 5 mg per day of prednisone for a 6 month period.

Group II: 0 mg prednisoneExperimental Treatment1 Intervention

Subjects will be randomized to 0 mg per day of prednisone dose for a 6 month period.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,834 Previous Clinical Trials

47,310,623 Total Patients Enrolled

Office of Rare Diseases (ORD)NIH

43 Previous Clinical Trials

12,317 Total Patients Enrolled

University of South FloridaLead Sponsor

407 Previous Clinical Trials

186,797 Total Patients Enrolled

Media Library

Prednisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT01933724 — 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: NCT01933724 — Phase 3

Prednisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01933724 — Phase 3

Frequently Asked Questions

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

Are people still being accepted into this research program?

"As of now, this clinical trial is not enrolling patients but was last updated on May 2nd, 2022. There are many other medical trials searching for participants right now though."

Answered by AI

What are the common treatments that use 5 mg prednisone?

"Prednisone at a dosage of 5mg is frequently used to manage thyroiditis but can also be taken for other conditions such as ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

At what dosage does the FDA sanction prednisone?

"5 mg prednisone is rated a 3 for safety by our team at Power. This is because Phase 3 trials have both efficacy data and multiple rounds of supporting safety data."

Answered by AI

What are the most similar investigations to the 5 mg prednisone study?

"To date, there have been 344 separate clinical trials conducted to study 5 mg prednisone. Of these active studies, 93 are in Phase 3. The majority of research is based out of Duarte, California; however, there are 16151 locations worldwide where trials for this medication are taking place."

Answered by AI

How many people can join this trial at most?

"This study is not looking for more participants at the moment. It was created on February 17th, 2014 and updated most recently on May 2nd, 2022. However, there are 43 other trials related to vasculitis recruiting patients and 344 studies involving 5 mg of prednisone that are currently enrolling participants."

Answered by AI

Recent research and studies

Journal of Medical Internet ResearchJournal

Experience with Direct-to-patient Recruitment for Enrollment into a Clinical Trial in a Rare Disease: A Web-based Study

Krischer, Jeffrey, Peter F Cronholm, Cristina Burroughs, Carol A McAlear, Renee Borchin, Ebony Easley, Trocon Davis, et al.. 2017. “Experience with Direct-to-patient Recruitment for Enrollment into a Clinical Trial in a Rare Disease: A Web-based Study”. Journal of Medical Internet Research. JMIR Publications Inc.. doi:10.2196/jmir.6798.

clinicaltrials.govStudy

The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach

2014. "The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01933724.