Granulomatosis With Polyangiitis Clinical Trial
— TAPIROfficial title:
The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach
Verified date | February 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 159 |
Est. completion date | December 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Center for Advancing Translational Sciences (NCATS), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Rare Diseases (ORD), Rare Diseases Clinical Research Network |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physician decision to increase glucocorticoids for disease relapse. | Six months | ||
Secondary | Time to disease flare. | 6 months | ||
Secondary | Safety outcomes. | Rate and type of serious adverse events and infections. | 6 months | |
Secondary | Protocol performance at VCRC Centers of Excellence. | Evaluation of patient characteristics, protocol compliance, participant retention, data completeness, timeliness of data entry, and data accuracy. | 6 months | |
Secondary | Health-related quality of life survey | Patient Reported Outcomes Measurement Information System (PROMIS) Assessment | Measured at baseline and end of the study | |
Secondary | Health-related quality of life surveys | Measured by Short Form-36 | Measured at baseline and the end of the study | |
Secondary | Health-related quality of life surveys | Measured by a Patient Global Assessment. | Measured at baseline, month 3, and end of the study |
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