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NCT01369355 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,282
- Enrollment target
NCT01369355: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01369355 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 1,282 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369355, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,282 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.
Primary Outcome
Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-b
Interventions
- DRUG Placebo IV
- DRUG Placebo SC
- DRUG Ustekinumab 90 mg SC q8w
- DRUG Ustekinumab 130 mg IV
- DRUG Ustekinumab 90 mg SC q12w
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,282 participants |
| Start Date | 2011-09-13 |
| Est. Completion | 2019-10-01 |
| Phase | Phase 3 |
What the finished NCT01369355 record still lists
NCT01369355 is an interventional study that assigns participants to a tested intervention. Its 1,282 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo IV is the first listed.
NCT01369355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369355 about?
NCT01369355 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)". The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275...
What is the current status of trial NCT01369355?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,282 participants. The study started on 2011-09-13. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT01369355?
The interventions under investigation include: Placebo IV (DRUG), Placebo SC (DRUG), Ustekinumab 90 mg SC q8w (DRUG), Ustekinumab 130 mg IV (DRUG), Ustekinumab 90 mg SC q12w (DRUG).
Who is sponsoring clinical trial NCT01369355?
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 NCT01369355's enrollment target sits among peer trials
1,282 198th of 2000 higher than 1,803 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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