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CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring (INFORM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00707512
Recruitment Status : Terminated (Sponsor's decision.)
First Posted : July 1, 2008
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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).

Condition or disease Intervention/treatment
Crohn's Disease Drug: natalizumab

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
Study Start Date : June 2008
Estimated Primary Completion Date : August 2050
Estimated Study Completion Date : August 2050

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Natalizumab


Intervention Details:
  • Drug: natalizumab
    Administered as specified in the TOUCH Prescribing Program
    Other Names:
    • Tysabri
    • BG00002


Primary Outcome Measures :
  1. Rate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab [ Time Frame: Every 6 months for up to 5 years following the first Tysabri infusion ]

Secondary Outcome Measures :
  1. Measurement of disease severity over time as assessed by change in HBI [ Time Frame: Every 6 months for up to 5 years following the first Tysabri infusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

Key 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.

Key Exclusion criteria:

  • None

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707512


Locations
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United States, Arizona
Research site
Scottsdale, Arizona, United States, 85260-1315
United States, California
Research site
Oceanside, California, United States, 92056-4457
Research site
San Francisco, California, United States, 94115
United States, Connecticut
Research site
Hamden, Connecticut, United States, 06518
Research site
Hartford, Connecticut, United States, 06106-3322
United States, Florida
Research site
Gainesville, Florida, United States, 32610-3003
Research site
Miami, Florida, United States, 33136
Research site
Winter Park, Florida, United States, 32789
United States, Georgia
Research site
Atlanta, Georgia, United States, 30342-5000
United States, Kentucky
Research site
Crestview Hills, Kentucky, United States, 41017-3409
Research site
Lexington, Kentucky, United States, 40536-0298
Research site
Louisville, Kentucky, United States, 40202
United States, Maryland
Research site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Research site
Boston, Massachusetts, United States, 02114
Research site
Boston, Massachusetts, United States, 02215
United States, Michigan
Research site
Ann Arbor, Michigan, United States, 48109-0361
United States, Minnesota
Research site
Plymouth, Minnesota, United States, 55446
United States, Missouri
Research site
Columbia, Missouri, United States, 65201
United States, New Hampshire
Research site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Research site
Egg Harbour Township, New Jersey, United States, 08234-5857
United States, New York
Research site
Great Neck, New York, United States, 11021
Research site
Lake Success, New York, United States, 11042-1008
Research site
New York, New York, United States, 10021
Research site
Rochester, New York, United States, 55905
Research site
Troy, New York, United States, 48084-5435
United States, North Carolina
Research site
Chapel Hill, North Carolina, United States, 27599-7080
Research site
Charlotte, North Carolina, United States, 28207
Research site
Raleigh, North Carolina, United States, 27607-6688
United States, Ohio
Research site
Cincinnati, Ohio, United States, 45219
Research site
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Research site
Providence, Rhode Island, United States, 02904
United States, Tennessee
Research site
Nashville, Tennessee, United States, 37232
United States, Texas
Research site
Grapevine, Texas, United States, 76051
Research site
Houston, Texas, United States, 77030
United States, Washington
Research site
Tacoma, Washington, United States, 98405
Puerto Rico
Research site
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00707512    
Other Study ID Numbers: 101CD401
ELN100226-CD451 ( Other Identifier: Elan Pharmaceuticals )
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs