The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach (TAPIR)
This study is a multi-center randomized controlled trial to evaluate the effects of using low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the duration of the study (approximately six months) or until a study endpoint.
Granulomatosis With Polyangiitis
Drug: Prednisone 5 mg/day
Drug: Prednisone 0 mg/day
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach|
- Physician decision to increase glucocorticoids for disease relapse. [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Time to disease flare. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety outcomes. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Rate and type of serious adverse events and infections.
- Protocol performance at VCRC Centers of Excellence. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluation of patient characteristics, protocol compliance, participant retention, data completeness, timeliness of data entry, and data accuracy.
- Health-related quality of life survey [ Time Frame: Measured at baseline and end of the study ] [ Designated as safety issue: No ]Patient Reported Outcomes Measurement Information System (PROMIS) Assessment
- Health-related quality of life surveys [ Time Frame: Measured at baseline and the end of the study ] [ Designated as safety issue: No ]Measured by Short Form-36
- Health-related quality of life surveys [ Time Frame: Measured at baseline, month 3, and end of the study ] [ Designated as safety issue: No ]Measured by a Patient Global Assessment.
|Study Start Date:||February 2014|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: 5 mg Prednisone
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
Drug: Prednisone 5 mg/day
Subjects will remain on daily prednisone dose of 5 mg
Experimental: 0 mg Prednisone
Subjects will be randomized to taper their prednisone dose from 5 mg per day to 0 mg per day for a 6 month period.
Drug: Prednisone 0 mg/day
Subjects will taper their prednisone dose from 5 mg per day to 0 mg per day
Patients with granulomatosis with polyangiitis (GPA, Wegener's) will be recruited at one of the Vasculitis Centers of Excellence. Participants will be randomized 1:1 either to taper their prednisone dose down to 5 mg/day according to a standardized schedule and stay at 5 mg/day of prednisone for the duration of the study or until a study endpoint, or taper their prednisone dose down to 0 mg/day using a standard schedule and stay at 0 mg/day for the duration of the study or until a study endpoint. All study participants will be followed for 6 months (from reaching a prednisone dose of 5 mg/day) or until an increase of prednisone dose (after randomization) occurs, whichever comes first.
Participants will have up to four study visits, a screening visit (visit 1), a baseline (visit 2), a month 3 visit (visit 3) and a month 6 or flare visit (visit 3) and up to two follow-up phone calls from the study coordinator at randomization and at month 1 (randomization and 1 month phone call may be combined if randomization occurs at month 1).
This study is a project of the Vasculitis Clinical Research Consortium (VCRC) funded through the National Institutes of Health Rare Diseases Clinical Research Network (RDCRN) with the purpose of promoting vasculitis research. The VCRC is the major clinical research infrastructure in North America for the study of vasculitis, and eight VCRC Centers of Excellence will be recruiting for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940094
|Contact: Carol McAlear, MAfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Cindy Beinhorn email@example.com|
|Principal Investigator: Ulrich Specks, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Katie Gartner firstname.lastname@example.org|
|Principal Investigator: Carol A Langford, MD, MHS|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Brian Rice Brian.Rice@uphs.upenn.edu|
|Principal Investigator: Peter A Merkel, MD, MPH|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Dawn McBride, RN email@example.com|
|Principal Investigator: Larry Moreland, MD|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Julieanne Nielsen Julieanne.Nielsen@hsc.utah.edu|
|Principal Investigator: Curry Koening, MD, MS|
|St. Joseph's Healthcare||Recruiting|
|Hamilton, Ontario, Canada|
|Contact: Sandra Messier firstname.lastname@example.org|
|Principal Investigator: Nader Khalidi, MD|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T 3L9|
|Contact: Sam Jagadeesh email@example.com|
|Principal Investigator: Simon Carette, MD|
|Principal Investigator:||Peter A Merkel, MD, MPH||University of Pennsylvania|
|Principal Investigator:||Jeffery P Krischer, PhD||University of South Florida|