NCT01940094

The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach

The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center randomized controlled trial to evaluate the effects of using low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the duration of the study (approximately six months) or until a study endpoint.

Detailed description

Patients with granulomatosis with polyangiitis (GPA, Wegener's) will be recruited at one of the Vasculitis Centers of Excellence. Participants will be randomized 1:1 either to taper their prednisone dose down to 5 mg/day according to a standardized schedule and stay at 5 mg/day of prednisone for the duration of the study or until a study endpoint, or taper their prednisone dose down to 0 mg/day using a standard schedule and stay at 0 mg/day for the duration of the study or until a study endpoint. All study participants will be followed for 6 months (from reaching a prednisone dose of 5 mg/day) or until an increase of prednisone dose (after randomization) occurs, whichever comes first. Participants will have up to four study visits, a screening visit (visit 1), a baseline (visit 2), a month 3 visit (visit 3) and a month 6 or flare visit (visit 3) and up to two follow-up phone calls from the study coordinator at randomization and at month 1 (randomization and 1 month phone call may be combined if randomization occurs at month 1). This study is a project of the Vasculitis Clinical Research Consortium (VCRC) funded through the National Institutes of Health Rare Diseases Clinical Research Network (RDCRN) with the purpose of promoting vasculitis research. The VCRC is the major clinical research infrastructure in North America for the study of vasculitis, and eight VCRC Centers of Excellence will be recruiting for this study.

Conditions

• Granulomatosis With Polyangiitis

Interventions

Type	Name	Description
DRUG	5 mg Prednisone	Subjects will remain on daily prednisone dose of 5 mg
DRUG	0 mg Prednisone	Subjects will taper their prednisone dose from 5 mg per day to 0 mg per day

Timeline

• Start date: 2014-02-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2013-09-11
• Last updated: 2026-03-30

Locations

9 sites across 2 countries: United States, Canada