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NCT00295282 · ClinicalTrials.gov registry record · Phase 1
A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis
A Phase 1 study of Ulcerative Colitis, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 5
- Study locations
NCT00295282: Completed Phase 1 study of Ulcerative Colitis, sponsored by Bristol-Myers Squibb.
NCT00295282 is a Phase 1 study of Ulcerative Colitis that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 24 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00295282, a Phase 1 study of Ulcerative Colitis, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg. Three to six patients will be enrolled at each dose level, starting at the lowest dose level, for a maximum of 24 patients to be enrolled into the study. The study is designed to establish the safety and tolerability of single doses of MDX-1100 administered in dose-escalating cohorts to patients with ulcerative colitis. Other study objectives include characterizing a pharmacokinetic profile and pharmacodynamic effects of MDX-1100 and determination of immunogenic response to MDX-1100.
Conditions Studied
Interventions
- DRUG MDX-1100 (anti-CXCL10 human monoclonal antibody)
Study Locations (5)
California
- Cedars-Sinai Medical Center - Los Angeles
Florida
- DMI Health Care Group, Inc. - Largo
Maryland
- Metropolitan Gastroenterology Group, PC - Chevy Chase
New Jersey
- University of Medicine and Dentistry of New Jersery (UMDNJ) - New Brunswick
New York
- Mount Sinai School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-01 |
| Phase | Phase 1 |
What the finished NCT00295282 record still lists
NCT00295282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which MDX-1100 (anti-CXCL10 human monoclonal antibody) is the first listed.
NCT00295282 lists 5 locations in 5 states (California, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT00295282 about?
NCT00295282 is a clinical study titled "A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis". This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg. Three to six patients will be enrolled at each dose level, starting at the lowest dose level, for a maximum of 24 ...
What is the current status of trial NCT00295282?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2006-01. Estimated completion is 2008-01.
What conditions does trial NCT00295282 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT00295282?
The interventions under investigation include: MDX-1100 (anti-CXCL10 human monoclonal antibody) (DRUG).
Who is sponsoring clinical trial NCT00295282?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00295282 being conducted?
This trial has 5 study locations across California, Florida, Maryland, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00295282's enrollment target sits among peer trials
24 109th of 122 higher than 14 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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