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APTITUDE

A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis

APTITUDE

A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis
Funding Versus Arthritis
Portfolio Paediatric, foetal and maternal health
Interventions Medicine
Randomised False
Status Completed
Start Date 01-Feb-2015

The CLUSTER consortium (https://www.clusterconsortium.org.uk/) are conducting further research into JIA and JIA-uveitis and have applied for approval to access your NHS number and participant ID in order to access your clinical and biological data that were collected during the SYCAMORE/APTITUDE trial. The Health Research Authority, on advice from the Confidentiality Advisory Group (CAG), has provided support under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 in order to provide a legal basis to process confidential information without consent.

 

This information will be used to identify your participation in and link your data to other JIA studies involved in CLUSTER.

 

These data will be shared with CLUSTER on 20th October 2022.

 

If you would like to opt-out of your data being shared with CLUSTER, please contact LCTC (lctcqa@liverpool.ac.uk) on or before this date. After this date, your data will be in the possession of CLUSTER and you should contact the CLUSTER consortium (info@clusterconsortium.org.uk).

 

 

Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. Children with JIA are at risk of inflammation of the uvea in the eye (uveitis).

In the initial stages of mild to moderate inflammation the uveitis is entirely asymptomatic. This has led to the current practice of screening all children with JIA regularly for uveitis.
Children with mild-moderate uveitis are treated with a combination of topical steroid drops and systemic Methotrexate. Methotrexate is an immunosuppressive drug that is used to treat inflammatory diseases including uveitis.

Previous research into combatting JIA-associated uveitis in children includes the SYCAMORE Trial, this was conducted by the APTITUDE team to assess the efficacy and safety of adamilumab, a monoclonal anti-Tumour Necrosis (anti-TNF) factor agent in the management of Methotrexate-refractory uveitis. The APTITUDE trial was complimentary to SYCAMORE as any potential patients who failed on anti-TNF therapy or who were not eligible for inclusion into SYCAMORE were eligible for the APTITUDE trial.

Tocilizumab (trade name RoActemra) is a biological therapy which blocks the action of interleukin (IL)-6. In arthritis, IL-6 causes tiredness, anaemia, and inflammation and damage to bones, cartilage and tissue. Tocilizumab reduces these effects.

The purpose of the study was to look at how effective the use of Tocilizumab in combination with Methotrexate was for the treatment of JIA- associated uveitis. The primary objective of this trial was to estimate the response rate to Tocilizumab in combination with MTX in children with JIA-associated uveitis who have already failed anti-TNF therapy.

Publications

  • Ramanan AV, Dick AD, Guly C, Hardwick B, Hickey H, Jones AP, Lee R, McKay A, Beresford M. A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis (APTITUDE TRIAL). BMC Rheumatology, 2018, Volume 2, Number 1, Page 1.
  • Ramanan AV, Dick AD, Guly C, McKay A, Jones AP , Hardwick B, Lee RWJ, Smyth M, Jaki T, Beresford MW; APTITUDE Trial Management Group. Tocilzumab in patines with anti-TNF refractory juvenile idiopathic arthritis associated uveitis (APTITUDE): a multicentr, single-arm, phase 2 trial. Lacent Rheumatol. 2020 Feb 7; 2(3).