GO-LEVEL
Research type
Research Study
Full title
Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels
IRAS ID
194917
Contact name
Helen Critchley
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Eudract number
2017-001374-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Summary of Research
Golimumab is a new treatment option for patients suffering from ulcerative colitis (UC). It has been proven to be effective in controlling the condition in large-scale, high quality clinical trials. However, a large proportion of patients will still fail to gain a meaningful benefit from the treatment. The reasons underlying this poor response to golimumab are not yet entirely understood.Summary of results
The GO-LEVEL study offers further evidence of a link between higher levels of golimumab in blood and better treatment outcomes in ulcerative colitis. This information can help to ensure that the medication is appropriately dosed, to give it the best chance of working well.It has been suggested that the levels of golimumab in the blood of patients who respond less well to treatment are lower than those who have a good response. We have designed a study to investigate this suggestion and, if proved to be correct, try to identify a level of drug in the blood that clinicians could aim for as a target to give their patients the best chance of having a good outcome when being treated with golimumab. This will involve observing how well patients respond to the treatment, whilst also measuring levels of the drug in their blood at certain points. As well as seeing how well symptoms are controlled, we will also measure how well the inflammation is controlled using blood and stool tests.
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1066
Date of REC Opinion
10 Jul 2017
REC opinion
Favourable Opinion