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

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

• Granulomatosis With Polyangiitis (Wegener's)
• Granulomatosis With Polyangiitis
• Wegener's Granulomatosis
• ANCA-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.

Sponsors & Collaborators

• The Cleveland Clinic

  collaborator OTHER

• Bristol-Myers Squibb

  collaborator INDUSTRY

• University of Pennsylvania

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

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

  collaborator NIH

• University of South Florida

  lead OTHER

Principal Investigators

• Carol A Langford, MD, MHS · The Cleveland Clinic

• Jeffrey P Krischer, PhD · University of South Florida

• Peter A Merkel, MD, MPH · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-25

Primary Completion

2023-07-25

Completion

2023-12-20

FDA Drug

Yes

Countries

• United States
• Canada
• Germany
• Ireland
• United Kingdom

Study Locations