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

Inclusion criteria

• ✓. 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:
• ✓. 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.
• ✓.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.