STARDUST - CNTO1275CRD3005
Research type
Research Study
Full title
STARDUST: Study on Treat to Target vs Routine Care maintenance strategies in Crohns Disease patients treated with ustekinumab
IRAS ID
218692
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2016-002918-43
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
Ustekinumab is an experimental drug that is being tested to see if it may be useful in treating Crohn’s Disease. The purpose of this study is to compare two different strategies of treatment with Ustekinumab in patients with Crohn’s Disease and to see if one strategy works better than the other. The safety of Ustekinumab will also be monitored. The 2 different treatment strategies are Treat to target versus routine care
A ‘treat to target’ strategy has been advocated as an optimized management approach for various diseases, by which strictly defined treatment targets facilitate decision making in clinical practice. Key to the success of this treatment strategy is the definition of appropriate treatment targets and adoption of algorithms that drive therapeutic changes within distinct time frames. This approach has been shown to be successful in chronic, immune-mediated inflammatory disorders such as rheumatoid arthritis and psoriatic arthritis. Recently, the value of such an approach in patients’ management has been suggested for IBD.
A target of 650 adult male and female subjects with endoscopic evidence of active disease will be enrolled. Subjects enrolled will have previously had an inadequate response with, lost response to, been intolerant to, or had medical contraindications to either conventional therapy, or one previous biologic therapy approved for the treatment of Crohn’s disease in the countries in which the study is conducted. Study subjects may be biologic-naïve or biologic-experienced, having received no more than one prior biologic for the treatment of Crohn’s disease.
REC name
West of Scotland REC 1
REC reference
17/WS/0008
Date of REC Opinion
28 Feb 2017
REC opinion
Further Information Favourable Opinion