ADA-RA-CDx-2016 validation and verification study in patients with RA
Research type
Research Study
Full title
The effects of pharmacogenetic factors on the efficacy of adalimumab in the treatment of Rheumatoid Arthritis (RA): A prospective, multi-centre, clinical verification and validation study for an In-Vitro Diagnostics medical device.
IRAS ID
242729
Contact name
Tom Sheeran
Contact email
Sponsor organisation
Egis Pharmaceuticals, PLC
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
Rheumatoid arthritis is an autoimmune disease in which the body’s immune system, which normally protects its health by attacking foreign substances like bacteria and viruses, mistakenly attacks the joints. Rheumatoid arthritis causes pain, swelling, stiffness and loss of function in joints.
Patients who has been diagnosed with Rheumatoid Arthritis, and have been assigned to treatment with adalimumab will be asked to take part in the proposed study. Adalimumab is a medicine already approved for use in Rheumatoid Arthritis and during this study will be administered to patients according to the product labelling and the local standard of care.
Approximately 230 patients, from around 6 countries, will participate in this study for a period of approximately 12 months.
The purpose of this study is to show that a specific medical device, which is currently being developed by the study sponsor, can predict therapeutic response to adalimumab based on the procedure of determining gene expression profiles from patient’s peripheral blood sample. Predicting whether the patient would respond to the particular therapy is an unmet need in the clinical setting and would have a large effect on the use of medications by making treatment more cost-effective and providing patients the opportunity to receive personalised therapy. Current data suggests that 20-40% of RA patients fail to respond to biological treatment.
Study visits will be scheduled as per national recommendation for the Adalimumab treatment. Patients will undergo study specific procedures which will include blood samples collection at 4 different clinic visits and completion of study specific questionnaire. All other assessments (including Adalimumab injection, other blood samples collection, disease assessment and quality of life evaluation) will be done as part of the routine clinical practice and management of patients with Rheumatoid Arthritis.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
18/WM/0243
Date of REC Opinion
7 Sep 2018
REC opinion
Further Information Favourable Opinion