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NCT02108860 · ClinicalTrials.gov registry record · Phase 3
Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)
A Phase 3 study of Wegener's Granulomatosis and Granulomatosis With Polyangiitis, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
- 20
- Study locations
NCT02108860: Completed Phase 3 study of Wegener's Granulomatosis and Granulomatosis With Polyangiitis, sponsored by University of South Florida.
NCT02108860 is a Phase 3 study of Wegener's Granulomatosis and Granulomatosis With Polyangiitis that has completed, run by University of South Florida. The registered enrollment target is 65 participants, roughly in line with the 66-participant average among 7 other Wegener's Granulomatosis trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02108860, a Phase 3 study of Wegener's Granulomatosis and Granulomatosis With Polyangiitis, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
- 20
- Study locations
Study Summary
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare. Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.
Primary Outcome
Treatment failure will be defined as relapse, disease worsening, or failure to achieve a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) = 0 or 1 by 6 months. Relapse will be defined as any of the following after remission: an increase in BVAS/WG, development of a new BVAS/WG item, or symptoms/signs of GPA that cannot be attributed to any cause other than GPA and that requires institution or dosage increase of prednisone. Disease worsening will be defined as any of
Conditions Studied
Interventions
- DRUG placebo
- DRUG Abatacept
Study Locations (20)
Other
- Medius Kliniken - Kirchheim unter Teck
- St. Vincent's University Hospital - Dublin
- University of Aberdeen - Aberdeen
- University of Cambridge- Addenbrookes Hospital - Cambridge
- Nottingham University Hospitals - Nottingham
- Royal Berkshire Hospital - Reading
Ontario
- St. Joseph's Hospital, Hamilton - Hamilton
- Mount Sinai Hospital, Toronto - Toronto
California
- Cedars Sinai Medical Center, Los Angeles - Los Angeles
Florida
- University of South Florida Rheumatology - Tampa
Kansas
- University of Kansas Medical Center - Kansas City
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic Rochester - Rochester
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2015-04-25 |
| Est. Completion | 2023-12-20 |
| Phase | Phase 3 |
What the finished NCT02108860 record still lists
NCT02108860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 66-participant average among 7 other Wegener's Granulomatosis trials with a reported enrollment target.
The record links to 4 conditions, with Wegener's Granulomatosis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT02108860 names 20 study sites across 14 states, led by Other, Ontario, California.
Frequently Asked Questions
What is clinical trial NCT02108860 about?
NCT02108860 is a clinical study titled "Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)". Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1:1 to receive either a...
What is the current status of trial NCT02108860?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2015-04-25. Estimated completion is 2023-12-20.
What conditions does trial NCT02108860 study?
This clinical trial studies the following conditions: Wegener's Granulomatosis, Granulomatosis With Polyangiitis, ANCA-Associated Vasculitis, Granulomatosis With Polyangiitis (Wegener's).
What interventions are being tested in trial NCT02108860?
The interventions under investigation include: placebo (DRUG), Abatacept (DRUG).
Who is sponsoring clinical trial NCT02108860?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02108860 being conducted?
This trial has 20 study locations across California, Florida, Kansas, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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