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

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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.

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
U.S. FDA Resources


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, Senior)
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:

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


  Show 36 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00707512     History of Changes
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:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs