Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission
1 other identifier
interventional
60
1 country
18
Brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. 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 ELN100226-351.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2002
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 4, 2003
CompletedFirst Posted
Study publicly available on registry
March 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedJune 16, 2016
March 1, 2012
1.2 years
March 4, 2003
June 14, 2016
Conditions
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (18)
Digestive Disease Associates
Gainesville, Florida, 32605, United States
Borland Groover Clinic
Jacksonville, Florida, 32223, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021, United States
Asheville Gastroenterology
Asheville, North Carolina, 28801, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Boice-Willis Clinic
Rocky Mount, North Carolina, 27804, United States
Columbia Gastroenterology Associates
Columbia, South Carolina, 29203, United States
Gastroenterology Center of the MidSouth
Memphis, Tennessee, 38120, United States
Memphis Gastroenterology Group
Memphis, Tennessee, 38120, United States
Austin Gastroenterology
Austin, Texas, 78745, United States
Internal Medicine Associates
Danville, Virginia, 24541, United States
Gastroenterology Consultants
Virginia Beach, Virginia, 23455, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Digestive Health Specialists
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2003
First Posted
March 6, 2003
Study Start
April 1, 2002
Primary Completion
July 1, 2003
Study Completion
July 1, 2003
Last Updated
June 16, 2016
Record last verified: 2012-03