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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 February 2023
• Main ID: NCT01933724
• Date of registration: 28/08/2013
• Prospective Registration: Yes
• Primary sponsor: University of South Florida
• Public title: The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach TAPIR
• Scientific title: The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach
• Date of first enrolment: February 17, 2014
• Target sample size: 12
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01933724
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Established diagnosis of granulomatosis with polyangiitis (GPA) (verified by medical
record review by the Protocol Oversight Management Team) 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:

1. Nasal or oral inflammation, defined as the development of painful or painless
oral ulcers or purulent or bloody nasal discharge

2. Abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates,
or cavities.

3. Active urinary sediment, defined as microscopic hematuria (>5 red blood cells per
high power field) or red blood cell casts

4. 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.

5. 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 = 5mg/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, rituximab, or
mycophenolate sodium. 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 for dose reduction or discontinuation for safety
purposes/toxicity) for the duration of the study.

7. Agreement from Treating Physician that 0mg/day of prednisone or 5mg/day of prednisone
is standard of care

8. Participant's Treating Physician is located in the United States

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

Wegener Granulomatosis

Vasculitis

Granulomatosis With Polyangiitis

Intervention(s)

Drug: 0 mg prednisone

Drug: 5 mg prednisone

Primary Outcome(s)

Prednisone dose increase for disease relapse [Time Frame: 6 months]

Secondary Outcome(s)

Protocol performance [Time Frame: 6 months]

Safety Outcomes [Time Frame: 6 months]

Time to event flare [Time Frame: 6 months]

Health related quality of life [Time Frame: 6 months]

Rates of disease flare sub types [Time Frame: 6 months]

Secondary ID(s)

R01HL115041

5526B

VCRC 5526B TAPIR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

Office of Rare Diseases (ORD)

National Heart, Lung, and Blood Institute (NHLBI)

Rare Diseases Clinical Research Network

National Center for Advancing Translational Sciences (NCATS)

National Institutes of Health (NIH)