TAPER
Research type
Research Study
Full title
Tapering of Biologics in Inflammatory Arthritis Patients in Remission
IRAS ID
281569
Contact name
Anne Barton
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 29 days
Research summary
We propose a feasibility study to see if we can perform a full trial of drug level and antidrug antibody testing. We are aware that tapering takes place in the NHS anyway. We are hoping this will guide biologic/ biosimilar tapering (reducing) decisions in UK patients with rheumatoid arthritis (RA). We think that measuring these drug levels and anti-drug antibodies in blood samples will be useful for guiding this process, but we can’t be sure until we test this.
If a patient is stable on their rheumatoid arthritis biologic or biosimilar, tapering the drug is often considered. However, it’s important to do this safely so the patient doesn’t experience a flare of their disease symptoms. This is why we would like to develop this guide.
We hope to recruit 50 patients with RA who would be considered for tapering by their standard care clinicians. The research will take place in 10 NHS Hospitals in England. Participants who are potential candidates for tapering will be recruited, a baseline questionnaire will be completed and baseline blood samples will be taken. Participants will then be randomised; clinicians will receive their drug level/ anti-drug antibody results for 50% of the participants and will not receive these results for the other 50% of the study participants. Immediately after randomisation, tapering can start. Blood samples will be taken at 6 and 12 months after the study starts at the participant’s recruiting site, and a participant questionaire will be completed at the same time. At the end of the study we'll ask for participant feedback.
This study is funded by a core grant from Versus Arthritis.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0173
Date of REC Opinion
31 Jul 2020
REC opinion
Further Information Favourable Opinion