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

Summary

This is a randomized controlled trial in patients with a diagnosis of granulomatosis with polyangiitis (GPA; Wegener's)that are in remission to evaluate the effects of using low-dose glucocorticoids ( 5 mg/day of prednisone) as compared to stopping glucocorticoid treatment entirely (0 mg/day of prednisone)on rates of disease relapse/disease flares.

This study is a novel approach to conducting a randomized clinical trial in the community setting. This study is being conducted in parallel with a similar study at established vasculitis institutions. This study will have a patient centric approach to research in that subjects will be recruited online and through social media and vasculitis support networks. Participants will be consented online and will receive care through their regular treating physician so no travel or additional doctor visits are required. Study participants will consent to the study and complete online questionnaires about their prednisone dose and about how they are feeling.

Conditions

• Granulomatosis With Polyangiitis
• Wegener Granulomatosis
• Vasculitis

Interventions

DRUG

5 mg prednisone

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

DRUG

0 mg prednisone

Subjects will be randomized to taper their prednisone dose to no prednisone for a 6 month period.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

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

  collaborator NIH

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• Office of Rare Diseases (ORD)

  collaborator NIH

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Rare Diseases Clinical Research Network

  collaborator NETWORK

• University of South Florida

  lead OTHER

Principal Investigators

• Peter A Merkel, MD, MPH · University of Pennsylvania

• Jeffrey P Krischer, PhD · University of South Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-17

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Drug

Yes

Countries

• United States

Study Locations