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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 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 1,282 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01369355
The ClinicalTrials.gov registry entry for NCT01369355 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo IV is the first listed.
NCT01369355 reports 0 study locations.
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.
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