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Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

Phase 2
Completed
Conditions
Crohn's Disease
Registration Number
NCT00055536
Lead Sponsor
Biogen
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (18)

Digestive Disease Associates

🇺🇸

Gainesville, Florida, United States

Borland Groover Clinic

🇺🇸

Jacksonville, Florida, United States

Atlanta Gastroenterology Associates

🇺🇸

Atlanta, Georgia, United States

University of Kentucky Medical Center

🇺🇸

Lexington, Kentucky, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Mercury Street Medical

🇺🇸

Butte, Montana, United States

Long Island Clinical Research Associates, LLP

🇺🇸

Great Neck, New York, United States

Asheville Gastroenterology

🇺🇸

Asheville, North Carolina, United States

Wake Research Associates

🇺🇸

Raleigh, North Carolina, United States

Boice-Willis Clinic

🇺🇸

Rocky Mount, North Carolina, United States

Scroll for more (8 remaining)
Digestive Disease Associates
🇺🇸Gainesville, Florida, United States

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