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

NCT01940094 | Completed Phase 3 DMC

• 3 other identifiers: VCRC5526AR01HL115041U54AR057319
• Study Type: interventional
• Target: 159
• Locations: 2 countries
• Sites: 9

Brief 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

Keywords

Granulomatosis with polyangiitis; Wegener's granulomatosis; WG; GPA; ANCA-Associated Vasculitis; AAV; Vasculitis; Prednisone; Glucocorticoid; Taper

Outcome Measures

Primary Outcomes (1)

• Physician decision to increase glucocorticoids for disease relapse.

  Six months

Secondary Outcomes (6)

• Time to disease flare.

  6 months

• Safety outcomes.

  6 months

• Protocol performance at VCRC Centers of Excellence.

  6 months

• Health-related quality of life survey

  Measured at baseline and end of the study

• Health-related quality of life surveys

  Measured at baseline and the end of the study

Study Arms (2)

5 mg Prednisone

EXPERIMENTAL

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

Drug: 5 mg Prednisone

0 mg Prednisone

EXPERIMENTAL

Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.

Drug: 0 mg Prednisone

Interventions

5 mg Prednisone DRUG

Subjects will remain on daily prednisone dose of 5 mg

Also known as: •5 mg/day glucocorticoids, •5 mg/day prednisone, •5 mg/day steroids

5 mg Prednisone

0 mg Prednisone DRUG

Subjects will taper their prednisone dose from 5 mg per day to 0 mg per day

0 mg Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of granulomatosis with polyangiitis (GPA) where patients will need to meet at least 2 of the 5 for the classification of GPA, at least one of which must be criterion d or e:
• The modified American College of Rheumatology (ACR) criteria are:
• A. Nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge.
• B. Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities.
• C. Active urinary sediment, defined as microscopic hematuria (\>5 red blood cells per high power field) or red blood cell casts.
• D. Granulomatosis inflammation on biopsy, defined as histologic changes showing granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area. Note: Pauci-immune glomerulonephritis seen on kidney biopsy will suffice for this criterion.
• E. Positive anti-neutrophil cytoplasmic antibody (ANCA) test specific for proteinase-3 measures by enzyme-linked immunoassay.
• Patients who are myeloperoxidase (MPO) positive or ANCA negative are still eligible for this study if they meet the criteria above and are felt to have GPA.
• Active disease within the prior 12 months (initial presentation or relapse) that at time of active disease required treatment with prednisone \>20 mg/day.
• Disease remission at time of enrollment.
• Prednisone dose at time of enrollment of ≥ 5 mg/day and ≤ 20 mg/day.
• Participant age of 18 years or greater.
• If the patient is taking an immunosuppressive medication agent other than prednisone (maintenance agent) then the maintenance agent must be at a stable dose for one month prior to enrollment with no plans by the treating physician to change the dose (other than for safety purposes/toxicity) for the duration of the study (through the month 6 visit or early termination). Acceptable maintenance agents include azathioprine, leflunomide, 6-mercaptopurine, methotrexate, mycophenolate mofetil, mycophenolate sodium, or rituximab. Patients may be on trimethoprim/sulfamethoxazole (TMP/SMX) for use as either a maintenance agent or for prophylaxis for infection. TMP/SMX may be used in combination with other drugs.
• If the patient is regularly taking trimethoprim/sulfamethoxazole at any dose then the patient is eligible if there no plans by the treating physician to change the dose after enrollment (other than dose reduction or discontinuation for safety purposes/toxicity) for the duration of the study.

You may not qualify if:

• \. Comorbid condition that has moderate likelihood of requiring a course of prednisone within one year of enrollment (e.g. chronic obstructive pulmonary disease (COPD), asthma, adrenal insufficiency).

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Rare Diseases Clinical Research Network: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Office of Rare Diseases (ORD): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (9)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (1)

• Cronholm PF, Applequist J, Krischer J, Fontenot E, Davis T, Burroughs C, McAlear CA, Borchin R, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg SR, Merkel PA; Vasculitis Clinical Research Consortium. A study of implementation factors for a novel approach to clinical trials: constructs for consideration in the coordination of direct-to-patient online-based medical research. BMC Med Res Methodol. 2024 Oct 18;24(1):244. doi: 10.1186/s12874-024-02352-w.

  PMID: 39425055 DERIVED

Related Links

• Vasculitis Clinical Research Consortium

MeSH Terms

Conditions

Granulomatosis with Polyangiitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Vasculitis

Interventions

Prednisone; Glucocorticoids; Steroids

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Peter A Merkel, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Jeffery P Krischer, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Rheumatology, Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 11, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (2)