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NCT02407236 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Inflammatory Bowel Diseases and Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 961
- Enrollment target
- 20
- Study locations
NCT02407236: Completed Phase 3 study of Inflammatory Bowel Diseases and Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT02407236 is a Phase 3 study of Inflammatory Bowel Diseases and Colitis, Ulcerative that has completed, run by Janssen Research & Development. The registered enrollment target is 961 participants, below the 42,241-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02407236, a Phase 3 study of Inflammatory Bowel Diseases and Colitis, Ulcerative, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 961 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.
Primary Outcome
As per global definition, clinical remission is defined as a Mayo score less than or equal to (\<=)2 points, with no individual subscore greater than (\>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding \[RB\], endoscopy findings, and physician's global assessment \[PGA\]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher s
Conditions Studied
Interventions
- DRUG Placebo IV
- DRUG Placebo SC
- DRUG Ustekinumab IV
- DRUG Ustekinumab SC
Study Locations (20)
Florida
- - Gainesville
- - Largo
- - Miami
- - Port Orange
- - Tampa
- - Winter Park
- - Zephyrhills
California
- - La Mirada
- - Los Angeles
- - Newport Beach
- - Torrance
- - Vallejo
Georgia
- - Atlanta
- - Decatur
- - Macon
- - Suwanee
Alabama
- - Birmingham
Colorado
- - Lone Tree
Connecticut
- - Farmington
District of Columbia
- - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 961 participants |
| Start Date | 2015-07-10 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 3 |
What the finished NCT02407236 record still lists
NCT02407236 is an interventional study that assigns participants to a tested intervention. The registered 961 participants enrollment target is mid-sized for trials with a published cap, below the 42,241-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Inflammatory Bowel Diseases appearing as the primary indexed condition, and to 4 interventions - of which Placebo IV is the first listed.
NCT02407236 names 20 study sites across 7 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02407236 about?
NCT02407236 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with ...
What is the current status of trial NCT02407236?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 961 participants. The study started on 2015-07-10. Estimated completion is 2021-11-30.
What conditions does trial NCT02407236 study?
This clinical trial studies the following conditions: Inflammatory Bowel Diseases, Colitis, Ulcerative.
What interventions are being tested in trial NCT02407236?
The interventions under investigation include: Placebo IV (DRUG), Placebo SC (DRUG), Ustekinumab IV (DRUG), Ustekinumab SC (DRUG).
Who is sponsoring clinical trial NCT02407236?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02407236 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02407236's enrollment target sits among peer trials
961 6th of 48 higher than 43 of 48 other Inflammatory Bowel Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Diseases 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.
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