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Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (ABROGATE) Trial

Principal Investigator: Dr. Kam Shojania

Status: Ongoing

Granulomatosis with polyangiitis (GPA) – previously called Wegener’s granulomatosis – is a rare, treatable disease that causes inflammation of the blood vessels. This inflammation, also known as vasculitis, can destroy the affected vessels. The cause of GPA is unknown but this form of vasculitis affects small and medium blood vessels with a risk of organ injury, impacting the sinuses, lungs, and kidneys. The potential for serious organ damage means that GPA can be fatal if left untreated. Early diagnosis and treatment can lessen the chance of complications; however, disease relapse is common and occurs in over 50 per cent of patients.

CHÉOS Scientist Dr. Kam Shojania is taking part in a large, multi-centered international clinical trial that is testing the effectiveness of abatacept at preventing GPA relapse. Abatacept (CTLA4-IG) inhibits the activation of T-cells and is typically used in treatment of rheumatoid arthritis. The rationale for the study is that abatacept can interfere with the pathogenesis of GPA and in doing so encourages disease remission and reduces reliance on corticosteroids. The trial consists of 16 sites across Canada and the United States.

Dr. Shojania is the principal investigator for the Vancouver site at St. Paul’s Hospital’s Rheumatology Clinic, where CHÉOS staff are coordinating site activities. The ABROGATE trial, which began in April of this year, is enrolling 150 participants. Trial participants are randomized to either an abatacept or placebo group and continue their regular glucocorticoid plus immunosuppressive agent treatment. The rate of disease remission or improvement will be compared between the groups. The full trial is a follow-up to a recently published pilot trial which demonstrated the tolerability and efficacy of abatacept for this purpose, listed below.

More information at ClinicalTrials.gov.

Langford CA, Monach PA, Specks U, Seo P, Cuthbertson D, McAlear CA, Ytterberg SR, Hoffman GS, Krischer JP, Merkel PA, Vasculitis Clinical Research Consortium. An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener’s). Annals of the rheumatic diseases. 2014;73(7):1376-9.

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