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

NCT ID: NCT00055536

Last Updated: 2016-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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natalizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elan Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Digestive Disease Associates

Gainesville, Florida, United States

Site Status

Borland Groover Clinic

Jacksonville, Florida, United States

Site Status

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Site Status

University of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Mercury Street Medical

Butte, Montana, United States

Site Status

Long Island Clinical Research Associates, LLP

Great Neck, New York, United States

Site Status

Asheville Gastroenterology

Asheville, North Carolina, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

Boice-Willis Clinic

Rocky Mount, North Carolina, United States

Site Status

Columbia Gastroenterology Associates

Columbia, South Carolina, United States

Site Status

Gastroenterology Center of the MidSouth

Memphis, Tennessee, United States

Site Status

Memphis Gastroenterology Group

Memphis, Tennessee, United States

Site Status

Austin Gastroenterology

Austin, Texas, United States

Site Status

Internal Medicine Associates

Danville, Virginia, United States

Site Status

Gastroenterology Consultants

Virginia Beach, Virginia, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Digestive Health Specialists

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CD306

Identifier Type: -

Identifier Source: org_study_id

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