PROTEA
Research type
Research Study
Full title
PROgnosis of TEmporal Arteritis
IRAS ID
240561
Contact name
Raashid Luqmani
Contact email
Sponsor organisation
Clinical Trial & Research Governance
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
We will examine the natural history of a condition called temporal arteritis (also called Giant Cell Arteritis - GCA) over 10 years in order to identify risk factors associated with more severe disease. GCA is a condition involving inflammation of blood vessels (we call this “vasculitis”). It usually affects arteries around the head area. It causes narrowing and sometimes blockage of some of these vessels. It can cause severe headache and may cause blindness. Treatment consists of high doses of steroids for long periods of time, with a significant risk of relapse on reducing the dose. Currently, all patients receive a similar course of treatment. We want to identify factors that predict whether the treatment could be adjusted according to severity, leading to a more rational basis for adjusting treatment, so that those patients with a more favourable outcome would receive less treatment, whilst those patients with more risk factors would be given more treatment.
The study includes three parts: 1) Collecting information in a database about each patient’s condition, recording information about possible factors which might make affect its severity, documenting its course over time, including clinical assessments, results of routine tests and questionnaires. 2) Take blood and urine samples over the first two years of the disease course (and review any temporal artery biopsy performed for routine care) 3) Assess temporal arteries (on the side of the head) and axillary arteries (in the arm pits) with an ultrasound scan. Ultrasound is a simple, safe and painless test which can be performed in a radiology department or in the clinic.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1123
Date of REC Opinion
28 Jun 2019
REC opinion
Favourable Opinion