Low-Dose Prednisone for Granulomatosis with Polyangiitis
(TAPIR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a small daily dose of prednisone, a type of steroid, can prevent flares in people with granulomatosis with polyangiitis (GPA), a disease that causes inflammation in blood vessels. Participants are randomly assigned to either continue with a low dose of prednisone or stop it completely, to determine which approach better prevents the disease from returning. Ideal participants have been diagnosed with GPA, experienced active disease in the past year requiring higher prednisone doses, are currently in remission, and take a stable dose of prednisone. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment option to market.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. If you are on an immunosuppressive medication other than prednisone, you must continue it at a stable dose for the study's duration. Your doctor should not plan to change the dose unless it's for safety reasons.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that low-dose prednisone is usually well-tolerated by people with granulomatosis with polyangiitis (GPA). One study found that only 4.2% of patients taking a low dose of prednisone experienced a relapse, compared to a higher relapse rate of 15.5% in those who stopped taking it completely.
Prednisone, even in low doses, acts quickly and often helps during disease flare-ups. However, even low doses can cause side effects like weight gain, mood changes, and higher blood sugar levels.
Overall, research suggests that low-dose prednisone is effective and generally safe for managing GPA, but discussing potential risks with a healthcare provider is always important.12345Why are researchers excited about this trial's treatment?
Researchers are excited about low-dose prednisone for granulomatosis with polyangiitis because it offers a potentially safer way to manage the condition. Unlike traditional high-dose steroid treatments, which can lead to significant side effects, this approach uses just 5 mg of prednisone daily. This lower dose aims to reduce the risk of complications while still providing effective control of inflammation. Additionally, there is an experimental arm with 0 mg prednisone, which could provide insights into the necessity and effectiveness of any prednisone use.
What evidence suggests that low-dose prednisone might be an effective treatment for granulomatosis with polyangiitis?
This trial will compare the effects of low-dose prednisone with no prednisone for granulomatosis with polyangiitis (GPA). Studies have shown that a low dose of prednisone can help prevent GPA flare-ups. Specifically, research indicates that only 4.2% of patients on a low dose experienced a flare-up, compared to 15.5% of those who stopped prednisone completely. Another study found that most patients achieved remission with both low and high doses of glucocorticoids, including prednisone. Patients have reported that prednisone works quickly, especially during flare-ups. Overall, these findings suggest that low-dose prednisone might help keep GPA under control and prevent flare-ups.23678
Who Is on the Research Team?
Peter Merkel, MD, MPH
Principal Investigator
University of Pennsylvania
Jeffrey P Krischer, PhD
Principal Investigator
University of South Florida
Are You a Good Fit for This Trial?
This trial is for adults over 18 with granulomatosis with polyangiitis (GPA), also known as Wegener's Granulomatosis, who are in remission but have had active disease within the last year. They must be on a stable dose of prednisone between 5mg and 20mg per day, with their doctor agreeing that either continuing or stopping prednisone is acceptable care.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either continue prednisone at 5 mg/day or taper to 0 mg/day for a 6 month period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Prednisone
Prednisone is already approved in United States, European Union, Canada for the following indications:
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Office of Rare Diseases (ORD)
Collaborator
National Institutes of Health (NIH)
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Rare Diseases Clinical Research Network
Collaborator