Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT01988961
Brief Summary:
The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe set panel (a genetic test) in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis (UC).
Detailed Description:
The study drug, golimumab, belongs to a group of medicines known as tumor necrosis factor (TNF) inhibitors and is approved in the United States, European Union, and Canada for treatment of UC. Studies have shown that people respond differently to treatment with TNF inhibitors and furthermore, some people may not actually respond to treatment. Tests which could predict the likelihood of response to golimumab prior to treatment would be of benefit to people with UC. This is an open label (physicians and participants know the identity of the assigned treatment), multicenter study to evaluate the accuracy of a genetic test (a subset of the length-109 probe set panel) in predicting response to golimumab treatment in patients with moderately to severely active UC. The study will consist of a screening phase, an open label treatment phase (Week 0 to Week 50), and a follow-up visit at Week 58. A subset of the length-109 probe set panel will be tested on samples obtained from colonic biopsies taken prior to treatment with golimumab for all participants at screening. All participants enrolled in the study will receive subcutaneous golimumab from Week 0 to Week 50; at the discretion of the investigator, participants will be given the option to self-administer golimumab from Week 6 onwards. Blood and fecal samples will be taken at various time points during the study; colonic biopsies will be taken at screening, Week 6, and Week 30; and endoscopies will be performed at Week 0, Week 6, and Week 30. The study duration for each participant is expected to be approximately 58 weeks. Participant safety will be monitored throughout the study.
Study:
NCT01988961
Study Brief:
Protocol Section:
NCT01988961