Clinical Trials Logo
  1. Home
  2. Granulomatosis With Polyangiitis
  3. NCT01940094

The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach — TAPIR  

Granulomatosis With Polyangiitis Clinical Trial

Official title:
The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01940094
Study type Interventional
Source University of Pennsylvania
Contact
Status Active, not recruiting
Phase Phase 3
Start date February 2014
Completion date December 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT01731561 - Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis Phase 3
Completed NCT01862068 - Neutrophils as Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener's Granulomatosis)
Completed NCT01750697 - A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Phase 2
Not yet recruiting NCT02126098 - Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis N/A
Terminated NCT01586858 - Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study N/A
Active, not recruiting NCT03919435 - TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis Phase 1/Phase 2
Not yet recruiting NCT04871191 - Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis Phase 2
Terminated NCT05376319 - PR3-AAV Resilient Remission or PRRR Phase 2
Not yet recruiting NCT05353179 - Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers Early Phase 1
Completed NCT02169219 - Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis Phase 4
Completed NCT01613599 - An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Active, not recruiting NCT05716334 - Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
Recruiting NCT04944524 - Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPA Phase 4
Completed NCT03430388 - Yellow Fever Vaccine in Patients With Rheumatic Diseases N/A
Completed NCT03410290 - Journey of Patients With Vasculitis From First Symptom to Diagnosis
Recruiting NCT03482479 - Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis Phase 2
Recruiting NCT01405807 - Alemtuzumab for ANCA Associated Refractory Vasculitis Phase 4
Active, not recruiting NCT01933724 - The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach Phase 3
Completed NCT05703802 - Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.
Active, not recruiting NCT03967925 - Rituximab and Belimumab Combination Therapy in PR3 Vasculitis Phase 2