Low-Dose Prednisone for Granulomatosis with Polyangiitis

(TAPIR Trial)

Recruiting in Tampa (>99 mi)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of South Florida

Must be taking: Prednisone

Disqualifiers: COPD, Asthma, Adrenal insufficiency

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized controlled trial in patients with a diagnosis of granulomatosis with polyangiitis (GPA; Wegener's)that are in remission to evaluate the effects of using low-dose glucocorticoids ( 5 mg/day of prednisone) as compared to stopping glucocorticoid treatment entirely (0 mg/day of prednisone)on rates of disease relapse/disease flares. This study is a novel approach to conducting a randomized clinical trial in the community setting. This study is being conducted in parallel with a similar study at established vasculitis institutions. This study will have a patient centric approach to research in that subjects will be recruited online and through social media and vasculitis support networks. Participants will be consented online and will receive care through their regular treating physician so no travel or additional doctor visits are required. Study participants will consent to the study and complete online questionnaires about their prednisone dose and about how they are feeling.

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 low-dose prednisone safe for humans?

Prednisone, a type of glucocorticoid, is generally effective but can have side effects like depression, anxiety, weight gain, and diabetes. Patients often find it fast-acting and effective, but they are concerned about these side effects and the process of reducing the dose. ^{1 2 3 4 5}

How is low-dose prednisone unique for treating granulomatosis with polyangiitis?

Low-dose prednisone is unique because it is a glucocorticoid (a type of steroid) that is fast-acting and effective at controlling symptoms, especially during diagnosis and relapses, but it is associated with side effects like weight gain and mood changes. It is often used in combination with other drugs like methotrexate to manage the condition. ^{1 2 6 7 8}

What data supports the effectiveness of the drug prednisone for treating granulomatosis with polyangiitis?

Research shows that prednisone, when used with other medications like cyclophosphamide, can lead to long-term remission in a high number of patients with granulomatosis with polyangiitis. Patients report that glucocorticoids like prednisone are fast-acting and effective, especially at the time of diagnosis and during relapses. ^{1 2 3 8 9}

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

You are taking between 5mg and 20mg of prednisone each day when you join the trial.

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

Your disease is not currently in remission.

Exclusion Criteria

You have a health condition that will likely need treatment with prednisone in the next year, like COPD, asthma, or adrenal insufficiency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either continue prednisone at 5 mg/day or taper to 0 mg/day for a 6 month period

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Prednisone

Trial Overview The TAPIR study compares the effects of continuing low-dose prednisone (5 mg/day) versus stopping it entirely in patients with GPA in remission. It aims to see which approach better prevents disease flares. Participants will manage their treatment online without extra travel.

How Is the Trial Designed?

Group I: 5 mg prednisone Experimental Treatment 1 Intervention

Subjects will be randomized to 5 mg per day of prednisone for a 6 month period.

Group II: 0 mg prednisone Experimental Treatment 1 Intervention

Subjects will be randomized to 0 mg per day of prednisone dose for a 6 month period.

Prednisone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Approved in European Union as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Approved in Canada as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Office of Rare Diseases (ORD)

Collaborator

Trials

44

Recruited

12,400+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Rare Diseases Clinical Research Network

Collaborator

Trials

69

Recruited

19,200+

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Patient perceptions of glucocorticoids in anti-neutrophil cytoplasmic antibody-associated vasculitis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Wegener's granulomatosis: prospective clinical and therapeutic experience with 85 patients for 21 years. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Rationale of concomitant cyclophosphamide for remission-induction in patients with antineutrophil cytoplasmic antibody-associated vasculitis: A propensity score-matched analysis of two nationwide prospective cohort studies. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Treatment of non-life threatening Wegener's granulomatosis with methotrexate and daily prednisone as the initial therapy of choice. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Long-term use and remission of granulomatosis with polyangiitis with the oral C5a receptor inhibitor avacopan. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Control of a relapse and induction of long-term remission of Wegener's granulomatosis by cyclosporine. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Maintenance of remission with leflunomide in Wegener's granulomatosis. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

An analysis of forty-two Wegener's granulomatosis patients treated with methotrexate and prednisone. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Infliximab therapy of relapsing tracheal stenosis in a pediatric patient with granulomatosis with polyangiitis: a case report. [2022]