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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT01940094
• Date of registration: 06/09/2013
• Prospective Registration: Yes
• Primary sponsor: University of Pennsylvania
• Public title: The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach TAPIR
• Scientific title: The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach
• Date of first enrolment: February 2014
• Target sample size: 159
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01940094
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Peter A Merkel, MD, MPH
• Affiliation: University of Pennsylvania

• Name: Jeffery P Krischer, PhD
• Affiliation: University of South Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. Active disease within the prior 12 months (initial presentation or relapse) that at
time of active disease required treatment with prednisone >20 mg/day.

3. Disease remission at time of enrollment.

4. Prednisone dose at time of enrollment of = 5 mg/day and = 20 mg/day.

5. Participant age of 18 years or greater.

6. 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.

6.1 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.

Exclusion Criteria:

1. 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Granulomatosis With Polyangiitis

Intervention(s)

Drug: 0 mg Prednisone

Drug: 5 mg Prednisone

Primary Outcome(s)

Physician decision to increase glucocorticoids for disease relapse. [Time Frame: Six months]

Secondary Outcome(s)

Safety outcomes. [Time Frame: 6 months]

Health-related quality of life surveys [Time Frame: Measured at baseline and the end of the study]

Time to disease flare. [Time Frame: 6 months]

Protocol performance at VCRC Centers of Excellence. [Time Frame: 6 months]

Health-related quality of life survey [Time Frame: Measured at baseline and end of the study]

Health-related quality of life surveys [Time Frame: Measured at baseline, month 3, and end of the study]

Secondary ID(s)

R01HL115041

U54AR057319

VCRC5526A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Office of Rare Diseases (ORD)

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

Rare Diseases Clinical Research Network

National Center for Advancing Translational Sciences (NCATS)

National Heart, Lung, and Blood Institute (NHLBI)