Abatacept for the Treatment of Giant Cell Arteritis

Recruiting Phase 3 Interventional Study
Giant Cell Arteritis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
78 (estimated)
Sponsor
University of Pennsylvania · Other
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About This Trial
This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment f…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. A diagnosis of newly diagnosed or relapsing GCA. Diagnostic criteria for GCA A patient will be said to have GCA by meeting 3 of 5 of the following modified ACR criteria for the classification of GCA in which 1 of the 3 must consist of criteria 4 or 5: 1. Age at disease…
Contacts

Carol McAlear, MA

7813214567

cmcalear@pennmedicine.upenn.edu

CONTACT