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CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

NCT ID: NCT00707512

Last Updated: 2024-06-03

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

TERMINATED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-05-28

Brief Summary

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The primary objective of the study is to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse event (SAE) in participants with Crohn's Disease (CD) treated with natalizumab. The secondary objective of this study in this study population is to evaluate disease severity over time in participants with CD treated with natalizumab based on changes in the Harvey-Bradshaw Index (HBI).

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Detailed Description

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This study was originally conducted by Elan Pharmaceuticals, Inc. (Elan) in collaboration with Biogen under a protocol written by Elan. Biogen is solely responsible for the study since April 2013.

Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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natalizumab

Administered as specified in the TOUCH Prescribing Program

Intervention Type DRUG

Other Intervention Names

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Tysabri BG00002

Eligibility Criteria

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Inclusion Criteria

* Subjects with Crohn's Disease (CD) who are eligible for therapy according to US Tysabri label and who are enrolled in the Tysabri Outreach Unified Commitment to Health (TOUCH) Prescribing Program.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research site

Scottsdale, Arizona, United States

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Oceanside, California, United States

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San Francisco, California, United States

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Hamden, Connecticut, United States

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Hartford, Connecticut, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Crestview Hills, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Plymouth, Minnesota, United States

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Columbia, Missouri, United States

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Lebanon, New Hampshire, United States

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Egg Harbor, New Jersey, United States

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Great Neck, New York, United States

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Lake Success, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Troy, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Providence, Rhode Island, United States

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Nashville, Tennessee, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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Tacoma, Washington, United States

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San Juan, , Puerto Rico

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Countries

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United States Puerto Rico

Other Identifiers

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ELN100226-CD451

Identifier Type: OTHER

Identifier Source: secondary_id

101CD401

Identifier Type: -

Identifier Source: org_study_id

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