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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 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.

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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.

Conditions Studied

Wegener's Granulomatosis Granulomatosis With Polyangiitis ANCA-Associated Vasculitis Granulomatosis With Polyangiitis (Wegener's)

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

FieldValue
Enrollment Target 65 participants
Start Date 2015-04-25
Est. Completion 2023-12-20
Phase Phase 3

Sponsor

University of South Florida

252 total trials

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What the Registry Record Tells You About NCT02108860

The ClinicalTrials.gov registry entry for NCT02108860 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 66-participant average among 7 other Wegener's Granulomatosis trials with a reported enrollment target. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.