APTITUDE
Research type
Research Study
Full title
A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis.
IRAS ID
179095
Contact name
Diana Benton
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Eudract number
2015-001323-23
Duration of Study in the UK
4 years, 2 months, 30 days
Research summary
We wish to conduct a study to test whether adding Tocilizumab to Methotrexate treatment for children with severe uveitis will enable us to prevent the serious complications that can occur from uncontrolled uveitis in children with JIA. In this clinical trial we will recruit 22 patients with severe uveitis who have not responded or are not getting better on anti-TNF therapy (drugs such as adalimumab and infliximab). All children will receive Methotrexate (MTX) throughout. We wish to test the response rate to Tocilizumab in combination with MTX and determine whether further research into the use of this intervention for the treatment of severe, refractory uveitis should be conducted. All children will receive Tocilizumab in this trial. If there is a good response rate then we would be able to show that there is a need for further clinical trials. We also wish to conduct a preliminary evaluation of the short term safety and tolerability of Tocilizumab in combination with MTX, with regards to ocular complications of treatment, adverse events and laboratory assessments and also to assess the efficacy of treatment with Tocilizumab to permit reduction in concomitant medications (other medications they are receiving at the same time), in particular topical and parenteral steroids (administered by injection or drip)
REC name
London - South East Research Ethics Committee
REC reference
15/LO/0771
Date of REC Opinion
3 Jul 2015
REC opinion
Further Information Favourable Opinion