CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

This study has been terminated.
(Sponsor's decision.)
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00707512
First received: June 27, 2008
Last updated: July 16, 2015
Last verified: June 2015

June 27, 2008
July 16, 2015
June 2008
August 2050   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Incidence of serious and/or clinically significant infections, malignancies, and other SAEs in patients with CD treated with TYSABRI®
Complete list of historical versions of study NCT00707512 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Disease severity over time in CD patients treated with TYSABRI®.
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CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Not Provided
Crohn's Disease
Drug: natalizumab
Administered as specified in the TOUCH Prescribing Program
Other Names:
  • Tysabri
  • BG00002
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
87
August 2050
August 2050   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00707512
101CD401, ELN100226-CD451
No
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP