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CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00707512
First received: June 27, 2008
Last updated: November 3, 2014
Last verified: November 2014

June 27, 2008
November 3, 2014
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 TYSABRI® [ 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
Changes in the Harvey-Bradshaw Index (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
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 SAEs in participants with Crohn's Disease (CD) treated with Tysabri. The secondary objective of this study in this study population is to evaluate disease severity over time in participants with CD treated with Tysabri based on changes in the Harvey-Bradshaw Index (HBI).

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.
 
Recruiting
2000
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 TOUCH Prescribing Program.

Key Exclusion criteria:

  • None

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

Both
18 Years and older
No
Contact: Biogen Idec clinicaltrials@biogenidec.com
United States,   Puerto Rico
 
NCT00707512
101CD401, ELN100226-CD451
No
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
November 2014

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