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Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)
NCT02108860 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02108860
The ClinicalTrials.gov registry entry for NCT02108860 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 144 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02108860 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Ontario, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Granulomatosis With Polyangiitis (Wegener's), ANCA-Associated Vasculitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02108860?
The interventions under investigation include: placebo (DRUG), Abatacept (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02108860?
This trial is sponsored by University of South Florida, which has 144 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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