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

NCT01940094 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

  • Granulomatosis With Polyangiitis

Interventions

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

Sponsors & Collaborators

  • 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 Pennsylvania

    lead OTHER

Principal Investigators

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

  • Jeffery 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
2014-02-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940094 on ClinicalTrials.gov