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NCT01369342 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 640
- Enrollment target
NCT01369342: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01369342 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 640 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369342, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 640 participants
- Enrollment target
Study Summary
This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
Primary Outcome
Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A decrease in CDAI score over time indicates im
Interventions
- DRUG Group 2 ustekinumab 130 mg
- DRUG Group 3: ustekinumab approximately 6 mg/kg
- DRUG Group 1: Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT01369342 record still lists
NCT01369342 is an interventional study that assigns participants to a tested intervention. The registered 640 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Group 2 ustekinumab 130 mg is the first listed.
NCT01369342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369342 about?
NCT01369342 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)". This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
What is the current status of trial NCT01369342?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 640 participants. The study started on 2011-07. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01369342?
The interventions under investigation include: Group 2 ustekinumab 130 mg (DRUG), Group 3: ustekinumab approximately 6 mg/kg (DRUG), Group 1: Placebo (DRUG).
Who is sponsoring clinical trial NCT01369342?
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 NCT01369342's enrollment target sits among peer trials
640 576th of 2000 higher than 1,422 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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