Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis
IRAS ID
253279
Contact name
Veronique Seifert
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Developpement
Eudract number
2017-002988-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1200-2184, WHO universal trial number:
Duration of Study in the UK
2 years, 10 months, 13 days
Research summary
Giant cell arteritis (GCA) is a chronic condition that causes severe inflammation in blood vessels, commonly affecting arteries in the skull. It’s an autoimmune disease meaning the immune system attacks its own tissues. GCA symptoms are indicative of the blood vessels affected, e.g. headaches, jaw cramping and vision loss. GCA usually affects people aged over 50 and is more common in women.
The common used treatment for GCA are corticosteroids. Patients start on high dose corticosteroid therapy and then receive a long-term maintenance therapy. More than 85% of patients suffer from corticosteroid-related side effects associated with long term use. In addition, there is a high rate of relapse of the disease when corticosteroid therapy is reduced. Aside from corticosteroids, there are limited treatment options available for GCA patients. Thus, there remains a high unmet medical need for effective treatment for GCA patients which spares patients the toxicities of long-term corticosteroid therapy.
Research has shown that a protein called Interleukin-6 (IL-6) which is produced by immune cells is elevated in GCA patients and IL-6 levels correlate with the symptoms. Research suggests that blocking IL-6 action is an effective therapy option in GCA. Sarilumab is an antibody that targets IL-6 and blocks the proteins signally pathways. The purpose of this study is to assess the effectiveness and the side effects of Sarilumab when given to patients with GCA.
In this study we aim to enrol participants with GCA either with new onset or refractory (patients that are not responding to treatment) disease. The effect of sarilumab on clinical signs and symptoms of GCA will be assessed and compared to participants receiving placebo. We will look at the effect of sarilumab on sparing corticosteroid-related side effects. The blood levels of sarilumab will be analysed as well as biomarkers for inflammation and disease activity.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0016
Date of REC Opinion
4 Mar 2019
REC opinion
Further Information Favourable Opinion