Study of sirukumab (anti-IL-6 drug) for active giant cell arteritis
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis
IRAS ID
184843
Contact name
Professor Bhaskar Dasgupta
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2015-001758-14
Duration of Study in the UK
4 years, 4 months, 26 days
Research summary
Giant cell arteritis (GCA) is a condition in which medium and large arteries, usually in the head and neck, become inflamed. GCA causes headaches, jaw pain and blurred or double-vision. Blindness is the most serious complication of GCA. Many patients with GCA also present with polymyalgia and constitutional symptoms (e.g. low grade fever, weight loss, night sweats and anaemia). It affects older adults almost exclusively - the average age at onset of the disease is 70, and it rarely occurs in people younger than 50. Women are about three times more likely to develop GCA.
GCA is initially treated with high dose corticosteroids (such as prednisolone or prednisone) followed by a lowering of the dose. However, most patients develop side effects and disease relapse is common.
This study will determine if sirukumab may be useful in treating patients with GCA. The purpose of the study is to test how well sirukumab keeps GCA from returning once prednisone has been stopped. This study will also look to see if sirukumab has any important side effects and look at the side effects of prednisone.
Part A of the study is a 52 week double-blind treatment phase. Patients will be randomized to either 100mg or 50mg of sirukumab, or placebo, and their corticosteroid dose will be reduced over 3, 6 or 12 months. Visits will occur every 4 weeks.
Part B of the study is a 104 week long-term extension phase. Patients with active disease, patients who were unable to reduce their prednisone during Part A and those with a worsening of disease will be able to receive up to 52 weeks sirukumab during Part B. This will involve 9-10 visits over a 104 week period.
Study procedures include physical examination, vital signs, blood and urine samples, completion of questionnaires and disease assessments.
This study is sponsored by GSK. Approximately 204 patients will participate worldwide with 20 patients from 9 hospitals in the UK.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/1425
Date of REC Opinion
23 Oct 2015
REC opinion
Further Information Favourable Opinion