Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

PHASE3CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

April 25, 2015

Primary Completion Date

July 25, 2023

Study Completion Date

December 20, 2023

Conditions
Granulomatosis With Polyangiitis (Wegener's)Granulomatosis With PolyangiitisWegener's GranulomatosisANCA-Associated Vasculitis
Interventions
DRUG

Abatacept

Those randomized to abatacept will receive abatacept 125 mg administered by subcutaneous injection once a week Participants randomized to either the abatacept or the placebo arm 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. .

DRUG

placebo

Those randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week.

Trial Locations (20)

10021

Hospital for Special Surgery, New York

19104

University of Pennsylvania, Philadelphia

33612

University of South Florida Rheumatology, Tampa

37240

Vanderbilt University, Nashville

44195

Cleveland Clinic, Cleveland

48109

University of Michigan, Ann Arbor

55902

Mayo Clinic Rochester, Rochester

66160

University of Kansas Medical Center, Kansas City

73230

Medius Kliniken, Kirchheim unter Teck

90048

Cedars Sinai Medical Center, Los Angeles, Los Angeles

97239

Oregon Health & Science University, Portland

T3M 1M4

University of Calgary, Calgary

V6Z 1Y6

University of British Columbia, St. Paul's Rheumatology Clinic, Vancouver

Unknown

St. Joseph's Hospital, Hamilton, Hamilton

St. Vincent's University Hospital, Dublin

University of Cambridge- Addenbrookes Hospital, Cambridge

M5T 3L9

Mount Sinai Hospital, Toronto, Toronto

AB25 2ZD

University of Aberdeen, Aberdeen

NG7 2UH

Nottingham University Hospitals, Nottingham

RG1 5AN

Royal Berkshire Hospital, Reading

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Cleveland Clinic

OTHER

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

University of Pennsylvania

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

lead

University of South Florida

OTHER

NCT02108860 - Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) | Biotech Hunter | Biotech Hunter