Abatacept (CTLA4 Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)
Brief description of study
This is a clinical trial to determine the effectiveness and safety of the investigational drug, abatacept, in treating patients with granulomatosis with polyangiitis (GPA). GPA is a disease that causes swelling of the blood vessels (vasculitis). We are looking for participants with GPA who have had a disease flare (relapse) in the past 4 weeks. Enrolled participants will be randomized (like flipping a coin) to receive either abatacept or placebo (liquid that looks like the study drug but contains no medication). Participants will inject the abatacept or placebo one time a week for 1 year, and will have clinic visits every 3 months.
Detailed description of study
At each visit, participants will have a physical exam,
answer questionnaires, and give blood and urine samples. It is possible to be
in this study for up to 4 years. This study is a project of the Vasculitis
Clinical Research Consortium (VCRC), which is a consortium of investigators in
major North American vasculitis centers. The VCRC is funded through the National
Institutes of Health as a Rare Diseases Clinical Research Network with the
purpose of promoting research in vasculitis.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Vasculitis,Wegener's granulomatosis,Antibodies,Anti-Neutrophil Cytoplasmic,Anti neutrophilic cytoplasm antibody,Anti Neutrophil Cytoplasmic Antibody,Neutrophil cytoplasmic Ab,Antibody,Antineutrophil Cytoplasmic,Antibodies,Antineutrophil Cytoplasmic [Chemical/Ingredient],Anti-Neutrophil Cytoplasmic Antibodies,Anti-Neutrophil Cytoplasmic Antibody,Anti neutrophilic cytoplasm antibody (substance),Antibody,Anti-Neutrophil Cytoplasmic,Antineutrophil Cytoplasmic Antibodies,ANCA - Anti-neutroph cytopl ab,Antineutrophil cytoplasm antib,Anti Neutrophil Cytoplasmic Antibodies,Neutrophil cytoplasmic antibody,ANCA - Anti-neutrophil cytoplasmic antibody,Cytoplasmic Antibodies,Antineutrophil,antineutrophil cytoplasmic antibody (ANCA),Antineutrophil Cytoplasmic Antibody,Antibodies,Antineutrophil Cytoplasmic,Cytoplasmic Antibody,Anti-Neutrophil,Cytoplasmic Antibodies,Anti-Neutrophil,ANCA,Anticytoplasmic Neutrophil Antibody,Cytoplasmic Antibody,Antineutrophil,Granulomatosis with Polyangiit
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Age: Between 18 Years - 99 Years
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Gender: All
Updated on
14 Jul 2023.
Study ID: 820678