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NCT01988961 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT01988961: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT01988961 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01988961, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study 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).
Primary Outcome
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 6. 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.
Interventions
- BIOLOGICAL Golimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT01988961 record still lists
NCT01988961 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which Golimumab is the first listed.
NCT01988961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01988961 about?
NCT01988961 is a clinical study titled "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". 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).
What is the current status of trial NCT01988961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2013-12. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01988961?
The interventions under investigation include: Golimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01988961?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01988961's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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