Steroid showdown: can a tiny daily dose keep a rare disease at bay?
NCT ID NCT01940094
First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study looked at 159 people with granulomatosis with polyangiitis (GPA), a rare disease that causes inflammation of blood vessels. Participants were randomly assigned to either stay on a low 5 mg daily dose of prednisone or slowly stop it over six months. The goal was to see which approach better prevented disease flares without causing too many side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prednisone (a steroid drug)
- What this could lead to
- If successful, this could help doctors decide whether a low maintenance dose of prednisone is better than stopping it entirely to prevent disease flares in people with granulomatosis with polyangiitis.
- What could go wrong
- This is a completed phase 3 trial, but the results may not apply to all patients. Prednisone has known side effects like weight gain, high blood sugar, and increased infection risk, and the benefit of a very low dose may be small.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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159 people
The number who actually took part.
- Started
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Feb 2014
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mount Sinai Hospital
Toronto, Ontario, M5T 3L9, Canada
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St. Joseph's Healthcare
Hamilton, Ontario, Canada
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
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