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

Information source: Elan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Natalizumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Elan Pharmaceuticals

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

- Male and female patients at least 18 years of age with at least a six-month history

of Crohn's disease and who are currently receiving Remicade and are not in remission (CDAI greater than/equal to 150)

- Women must not be breastfeeding or pregnant, and must not become pregnant during the

study.

Locations and Contacts

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

Additional Information

Starting date: April 2002
Last updated: March 6, 2012

Page last updated: August 23, 2015

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