Trials / Completed
CompletedNCT00055367
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents With Moderately to Severely Active Crohn's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease. Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-352.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | natalizumab |
Timeline
- Start date
- 2002-04-01
- Primary completion
- 2004-05-01
- Completion
- 2004-05-01
- First posted
- 2003-02-28
- Last updated
- 2016-06-16
Locations
13 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT00055367. Inclusion in this directory is not an endorsement.