The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach (TAPIR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01940094|
Recruitment Status : Recruiting
First Posted : September 11, 2013
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Granulomatosis With Polyangiitis||Drug: 5 mg Prednisone Drug: 0 mg Prednisone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach|
|Actual Study Start Date :||February 2014|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: 5 mg Prednisone
Subjects will be randomized to a prednisone dose of 5 mg per day for a 6 month period.
Drug: 5 mg Prednisone
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: 0 mg Prednisone
Subjects will taper their prednisone dose from 5 mg per day to 0 mg per day
- Physician decision to increase glucocorticoids for disease relapse. [ Time Frame: Six months ]
- Time to disease flare. [ Time Frame: 6 months ]
- Safety outcomes. [ Time Frame: 6 months ]Rate and type of serious adverse events and infections.
- Protocol performance at VCRC Centers of Excellence. [ Time Frame: 6 months ]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 ]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 ]Measured by Short Form-36
- Health-related quality of life surveys [ Time Frame: Measured at baseline, month 3, and end of the study ]Measured by a Patient Global Assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940094
|Contact: Carol McAlear, MAfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118|
|Contact: Chris Zammitti email@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Sam Hughes Hughes.Samantha@mayo.edu|
|Principal Investigator: Ulrich Specks, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Elizbeth Kisela firstname.lastname@example.org|
|Principal Investigator: Carol A Langford, MD, MHS|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Roni Devassy Roni.Devassy@uphs.upenn.edu|
|Principal Investigator: Peter A Merkel, MD, MPH|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Laurie Hope email@example.com|
|Principal Investigator: Larry Moreland, MD|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Jessica gonzalez firstname.lastname@example.org|
|Principal Investigator: Curry Koening, MD, MS|
|St. Joseph's Healthcare||Recruiting|
|Hamilton, Ontario, Canada|
|Contact: Sandra Messier email@example.com|
|Principal Investigator: Nader Khalidi, MD|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T 3L9|
|Contact: Judy Vendramini firstname.lastname@example.org|
|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|