Treatment persistence with biologics in ulcerative colitis
Research type
Research Study
Full title
GO-RETRO: Non-interventional Retrospective Chart Review to assess Treatment Persistence in Ulcerative Colitis Patients receiving Anti-TNF Treatment (Golimumab or Adalimumbab)
IRAS ID
246799
Contact name
Syed Samiul Hoque
Contact email
Sponsor organisation
Merck Sharp & Dohme, a subsidiary of Merck & Co.
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 3 months, 17 days
Research summary
There aren’t many studies that have looked at how long patients are treated with certain drugs used to treat moderate to severe ulcerative colitis in the same study, especially a drug called golimumab. Treatment persistence is the term used to describe how long a patient stays on treatment. It shows how long the doctor (and/or patient) feel that the best course of action is for the patient to continue to receive a particular drug rather than trying something else.
This study will collect information on treatment persistence for golimumab and also a similar drug called adalimumab. It will describe the average time a patient stays on these drugs and the percentage of patients who discontinue within the first 12 months. In addition, the study will look at healthcare resource use associated with treatment with these two drugs e.g. by looking at the number of appointments patients have.
The study will collect data from 10-15 hospitals spread around the UK. Patients that will be part of the study will be those with ulcerative colitis and treated with either golimumab or adalimumab. However, the study will only collect historic data from the patient medical records by the healthcare team. Patients themselves do not need to do anything, there will be no changes to their care and they will not undergo any procedures as part of the research.
Overall, medical records will be identified for approximately 300 ulcerative colitis patients (100 treated with golimumab and 200 treated with adalimumab [20-30 patients per hospital]). Doctors (or their research teams) that have treated the patients identified for this study will fill out a form online in order to provide anonymized information about the patient’s treatment history. Data collection will last a few months to provide enough time to extract the data.REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/1712
Date of REC Opinion
2 Oct 2018
REC opinion
Favourable Opinion