The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach (TAPIR)
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.
|Granulomatosis With Polyangiitis Wegener Granulomatosis Vasculitis||Drug: 5 mg prednisone Drug: 0 mg prednisone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach|
- Prednisone dose increase for disease relapse [ Time Frame: 6 months ]Physician decision to increase prednisone dose for GPA disease relapse
- Rates of disease flare sub types [ Time Frame: 6 months ]Rates of GPA disease flare sub types: severe versus non-severe
- Time to event flare [ Time Frame: 6 months ]Time from randomization to GPA disease flare
- Health related quality of life [ Time Frame: 6 months ]Health related quality of life as assessed through the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire
- Safety Outcomes [ Time Frame: 6 months ]Serious adverse events and infections
- Protocol performance [ Time Frame: 6 months ]
- Patient characteristics
- Protocol compliance This study is being conducted in parallel to a study at VCRC clinical centers. Protocol performance will be assessed through comparison of participant retention, data completeness, timeliness of data entry, and data accuracy between the two studies.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: 5 mg prednisone
Subjects will be randomized to 5 mg per day of prednisone for a 6 month period.
Drug: 5 mg prednisone
Subjects will be randomized to take 5 mg per day of prednisone for a 6 month period.
Experimental: 0 mg prednisone
Subjects will be randomized to 0 mg per day of prednisone dose 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933724
|Contact: Jeffrey Krischer, PhD||1-888-443-1793||TAPIR@epi.usf.edu|
|United States, Florida|
|University of South Florida TAPIR Study Team||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Cristina Burroughs 888-443-1793 TAPIR@epi.usf.edu|
|Principal Investigator: Jeffrey Krischer, PhD|
|Principal Investigator:||Peter A Merkel, MD, MPH||University of Pennsylvania|
|Principal Investigator:||Jeffrey P Krischer, PhD||University of South Florida|