The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of South Florida
Collaborators:
National Center for Advancing Translational Science (NCATS) National Heart, Lung, and Blood Institute (NHLBI) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health (NIH) Office of Rare Diseases (ORD) Rare Diseases Clinical Research Network