Clinical Trial: A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative Colitis

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 Summary: 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.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: The area under the Receiver Operating Characteristic curve of a subset of the length-109 probe set panel as a predictor of mucosal healing at Week 6. [ Time Frame: Week 6 ]

Original Primary Outcome: The area under the Receiver Operating Characteristic curve of the length-109 probe set panel as a predictor of mucosal healing at Week 6. [ Time Frame: Week 6 ]

Current Secondary Outcome:

• The area under the Receiver Operating Characteristic curve of a subset of the length-109 probe set panel as a predictor of clinical response at Week 6 and at Week 30 [ Time Frame: Week 6 and Week 30 ]
  The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict clinical response. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting clinical response than "flipping a coin". Areas above 0.5 represent increasing accuracy.
• The area under the Receiver Operating Characteristic curve of a subset of the length-109 probe set panel as a predictor of clinical remission at Week 6 and at Week 30 [ Time Frame: Week 6 and Week 30 ]
  The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict clinical remission. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting clinical remission than "flipping a coin". Areas above 0.5 represent increasing accuracy.
• The area under the Receiver Operating Characteristic curve of a subset of the length-109 probe set panel as a predictor of mucosal healing at Week 30 [ Time Frame: Week 30 ]
  The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict mucosal healing at Week 30. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting mucosal healing than "flipping a coin". Areas above 0.5 represent increasing accuracy.

Original Secondary Outcome:

• The area under the Receiver Operating Characteristic curve of the length-109 probe set panel as a predictor of clinical response at Week 6 and at Week 30 [ Time Frame: Week 6 and Week 30 ]
  The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict clinical response. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting clinical response than "flipping a coin". Areas above 0.5 represent increasing accuracy.
• The area under the Receiver Operating Characteristic curve of the length-109 probe set panel as a predictor of clinical remission at Week 6 and at Week 30 [ Time Frame: Week 6 and Week 30 ]
  The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict clinical remission. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting clinical remission than "flipping a coin". Areas above 0.5 represent increasing accuracy.
• The area under the Receiver Operating Characteristic curve of the length-109 probe set panel as a predictor of mucosal healing at Week 30 [ Time Frame: Week 30 ]
  The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict mucosal healing at Week 30. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting mucosal healing than "flipping a coin". Areas above 0.5 represent increasing accuracy.

Dates:
Date Received: November 14, 2013
Date Started: December 2013
Date Completion:
Last Updated: January 4, 2017
Last Verified: December 2016