BIOTIPRA Feasibility Trial
Research type
Research Study
Full title
BIOmarker-guided Treatment decisions In Rheumatoid and Psoriatic Arthritis (BIOTIPRA); A Feasibility Study
IRAS ID
234848
Contact name
James Bluett
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Rheumatoid and psoriatic arthritis are disabling types of inflammatory arthritis caused by inflammation in the joints that can lead to pain, stiffness, joint damage and early death. In recent years, new biologic drugs have been developed that block the molecular pathways causing inflammation. Adalimumab and certolizumab block the TNF inflammatory pathway and are called TNF inhibitors (TNFi). Adalimumab and certolizumab are important drugs to study because they are used widely. These drugs are very effective in controlling inflammation for many patients but the do not work for everyone. Reasons such medications may not be effective include that the levels of the drug in the bloodstream are too low or that antibodies have formed against the medication to stop it working. We and others have shown that low drug levels and anti-drug antibodies at 3 and/or 6 months predict how well the patient will respond to the drug by 12 months. However, we don’t know whether introducing the testing will actually improve how well patients respond. The aim of a feasibility study is to assess the capability of running a full clinical trial, and to establish the number of patients required to power a full trial.
We will recruit 30 patients with rheumatoid or psoriatic arthritis who are about to start adalimumab or certolizumab. 15 patients will be asked to donate blood samples and complete questionnaires, but their treatment will continue as standard. For the other 15 patients the results of the blood tests will be fed back to their doctors with treatment advice. At the end of 12 months, we will assess whether the group of patients whose doctors received the results of the drug level and anti-drug antibody tests had a better overall outcome.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0021
Date of REC Opinion
6 Mar 2019
REC opinion
Further Information Favourable Opinion