NCT01933724

The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This open label pilot study will randomize 60 participants with GPA in remission affecting the sinonasal tract, oral mucosa, skin, musculoskeletal system, pulmonary parenchyma, or other disease features that warranted an administration of 20 mg/day or more within the last 12 months. At the time of enrollment, participants will need to be taking prednisone at a dose of ≥ 5mg/day and ≤ 20 mg/day. All enrolled participants will be instructed to reduce the daily dose of prednisone according to their treating physician. Once participants reach a prednisone dose of 5mg/day, they will be randomized at a 1:1 ratio to continue prednisone at 5 mg/day or to taper prednisone to 0 mg/day. Participants will be followed for approximately six months from reaching a prednisone dose of 5 mg/day. The primary study outcome is the proportion of participants who increase prednisone for disease relapse within 6 months of randomization. Participant data collected via this study will be combined with that from a complementary study conducted at Vasculitis Clinical Research Consortium (VCRC) clinical centers.

Conditions

• Granulomatosis With Polyangiitis
• Wegener Granulomatosis
• Vasculitis

Interventions

Type	Name	Description
DRUG	5 mg prednisone	Subjects will be randomized to take 5 mg per day of prednisone for a 6 month period.
DRUG	0 mg prednisone	Subjects will be randomized to taper their prednisone dose to no prednisone for a 6 month period.

Timeline

• Start date: 2014-02-17
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2013-09-02
• Last updated: 2024-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study