Gevokizumab Giant Cell Arteritis study
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled proof of concept study of the efficacy and the safety of gevokizumab in the treatment of patients with giant cell arteritis
IRAS ID
137458
Contact name
Bhaskar Dasgupta
Contact email
Sponsor organisation
I.R.I.S Institut de Recherches Internationales Servier
Eudract number
2013-002778-38
Clinicaltrials.gov Identifier
U1111-1144-7133, Universal Trial Number (UTN)
Research summary
This study is looking at the effectiveness and safety of Gevokizumab in patients with Giant Cell Arteritis. This disease is a rare inflammatory illness usually treated with corticosteroids. A total of 50 patients, male and female, aged over 50 years old, will partake in this study in around 20 countries worldwide. Patients must be treated with corticosteroid for GCA and once included in the study will be given either Gevokizumab or a dummy drug over 6 months, followed by a 6 month period with open label Gevokizumab treatment.
Gevokizumab acts as an anti-inflammatory antibody - regulating a protein (interleukin-1 beta) that promotes tissue inflammation. Pro-inflammatory proteins as Interleukin-1 beta have been shown to be implicated in the origin of giant cell arteritis. Thus, the study drug could improve symptoms in this chornic inflammatory vascular disease. In this study, 60 mg of gevokizumab will be injected every 4 weeks, over the course of 24 weeks (7 injections in total).
The efficacy will be evaluated with the proportion of responders to the treatment according to guidelines. The proportion of patients in remission with the study drug and low doses of corticosteroids will also be an effectiveness criterion. The safety evaluation involves the effect of gevokizumab versus the dummy drug regarding adverse events, vital signs, blood and urine analysis (blood cell counting, chemistry and specific immune proteins), heart check-up (electrocardiogram) and chest X-rays.
Patients will be asked to participate in an optional additional part of the study. The purpose of this sub-study is the analysis of genomic biomarkers. It allows to evaluate various characteristics of the genome (set of all genes) related to giant cell arteritis and to the patient's treatment. This will allow a better understanding of the disease and the efficacy and safety of the treatment.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1033
Date of REC Opinion
29 Jul 2014
REC opinion
Further Information Favourable Opinion