Artemis UK
Research type
Research Study
Full title
Abatacept Treatment in Polymyositis and Dermatomyositis
IRAS ID
81595
Contact name
Patrick Gordon
Sponsor organisation
Karolinska University Hospital
Eudract number
2009-015957-20
Clinicaltrials.gov Identifier
Research summary
Polymyositis and dermatomyositis are rare chronic inflammatory disorders for which no specific disease-targeting treatment has been developed. Our immune system is likely to play an important role in the development of polymyositis and dermatomyositis. It is thought that these diseases are caused when T-cells (a type of white blood cell that usually protects the body from infection) attack healthy tissue in the body. Abatacept is the active substance found in Orencia, a drug that targets the stimulation of T-cells and reduces their activity. Abatacept has been granted a marketing authorisation for the treatment of patients with rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, conditions also associated with irregular T-cell activity. This pilot study aims to investigate the effects of abatacept on disease activity in patients with polymyositis and dermatomyositis and also gain a better understanding of the underlying disease mechanisms that cause them, including the mechanisms which cause T-cells to have this autoimmune response. To enter the study, patients must have had persistent active inflammatory disease despite treatment with glucocorticoids and at least one immunosuppressive drug over a period of 3 months. Patients will be randomised to one of two arms (i) the active treatment arm in which abatacept will be administered to patients by intravenous infusion at weeks 1, 2, 4 and then every 4 weeks and (ii) the delayed start arm in which there will be a three month treatment delay period before the patients are administered the drug. In both arms, patients will be administered abatacept for a total of 6 months. This multi-centre trial will be taking place in three centres across Europe, aiming to recruit 20 patients (10 with polymyositis; 10 with dermatomyositis). The study will last for 9 months and patients will undergo safety and efficacy assessments for the duration of the trial.
REC name
London - Westminster Research Ethics Committee
REC reference
11/LO/1848
Date of REC Opinion
13 Feb 2012
REC opinion
Further Information Favourable Opinion