ABROGATE

Condition: Granulomatosis with polyangiitis

Eligibility

Key Inclusion Criteria

  • Best characterized as granulomatosis with polyangiitis (GPA) and not microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis and must have met at least 2 of the 5 modified American College of Rheumatology classification criteria for GPA
  • At least 15 years old
  • Both women and men must be willing to use an effective means of birth control while receiving treatment through this study

Key Exclusion Criteria

  • Does not meet the criteria for non-severe disease
  • Treatment with cyclophosphamide within 3 months prior to screening
  • Treatment with methylprednisolone 1000 mg within 28 days prior to enrollment

Full Study Name

Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener’s) (ABROGATE) (IRB no. 39773)

Summary

This study focuses on patients who have granulomatosis with polyangiitis (also known as Wegener's or GPA) and who currently have active disease that is non-severe and relapsing (having a recurrence of the disease). GPA is an illness characterized by inflammation of blood vessels (vasculitis). The purpose of the study is to determine the effectiveness and safety of a medication called abatacept. The current treatment for GPA is a combination of drugs, including prednisone (steroid medication) and other immunosuppressant medications. Although prednisone is effective, it is associated with side effects and does not prevent the occurrence of disease relapses.

Abatacept acts by interfering with an important step in inflammation that is called T cell (a specific type of white blood cell) activation. Researchers believe that T cell activation may be important in GPA, and abatacept may be beneficial in treating the disease. Participants will be randomly assigned to receive either abatacept or placebo (inactive substance).

Abatacept was approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, but it has not been approved by the FDA for the treatment of GPA.

Phase

Phase III

Principal Investigator

Lindsy Forbess, MD

Contact
Bonnie Paul
Phone: 310-423-2422
Email: bonnie.paul@cshs.org