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NCT03596645 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT03596645: Active Phase 3 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT03596645 is a Phase 3 study of Colitis, Ulcerative that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 84 participants, below the 403-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03596645, a Phase 3 study of Colitis, Ulcerative, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.
Primary Outcome
Percentage of participants with clinical remission at Week 6 as assessed by the Mayo score was reported. Clinical remission was defined as a Mayo score of less than or equal to (\<=) 2 point, with no individual sub-score greater than (\>) 1. The Mayo score was sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated a
Conditions Studied
Interventions
- DRUG Infliximab
- DRUG Golimumab
Study Locations (20)
Other
- Universitair Kinderziekenhuis Koningin Fabiola - Brussels
- Cliniques Universitaires Saint Luc - Brussels
- UZ Brussel - Jette
- MK Blumenau Pesquisa Clínica - Blumenau
- Hospital Pequeno Principe - Curitiba
- Irmandade Santa Casa de Misericordia de Porto Alegre - Porto Alegre
- BR Trials - São Paulo
- Hopital Pellegrin CHU Bordeaux - Bordeaux
Texas
- Children's Medical Center of Dallas - Dallas
- Cook Childrens Medical Center - Fort Worth
- DHAT Research Institute - Garland
Colorado
- Children's Hospital Colorado and University of Colorado - Aurora
- Rocky Mountain Pediatric Gastroenterology - Lone Tree
California
- University of California San Francisco - San Francisco
Connecticut
- Connecticut Children's Medical Center - Hartford
Delaware
- Nemours DuPont Hospital for Children - Wilmington
Georgia
- Children's Center for Digestive Health Care - Atlanta
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2027-02-20 |
| Phase | Phase 3 |
What the registry record for NCT03596645 still lists
NCT03596645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 403-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 2 interventions - of which Infliximab is the first listed.
NCT03596645 names 20 study sites across 10 states, led by Other, Texas, Colorado.
Frequently Asked Questions
What is clinical trial NCT03596645 about?
NCT03596645 is a clinical study titled "A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately t...
What is the current status of trial NCT03596645?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2018-10-29. Estimated completion is 2027-02-20.
What conditions does trial NCT03596645 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT03596645?
The interventions under investigation include: Infliximab (DRUG), Golimumab (DRUG).
Who is sponsoring clinical trial NCT03596645?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03596645 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colitis, Ulcerative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03596645's enrollment target sits among peer trials
84 23rd of 28 higher than 6 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative 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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