CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Elan Pharmaceuticals
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00707512
First received: June 27, 2008
Last updated: March 15, 2012
Last verified: March 2012

June 27, 2008
March 15, 2012
June 2008
June 2017   (final data collection date for primary outcome measure)
Incidence of serious and/or clinically significant infections, malignancies, and other SAEs in patients with CD treated with TYSABRI®
Same as current
Complete list of historical versions of study NCT00707512 on ClinicalTrials.gov Archive Site
Disease severity over time in CD patients treated with TYSABRI®.
Same as current
Not Provided
Not Provided
 
CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
Investigating Natalizumab Through Further Observational Research and Monitoring

The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events in patients with Crohn's Disease(CD) treated with TYSABRI® (Natalizumab)

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Specialty IBD clinics or GI clinical practices

Crohn's Disease
Drug: Natalizumab
This is an observational study to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse events in Crohn's disease patients treated with commercial Tysabri (Natalizumab). There is no additional drug administration during this observational study.
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
Not Provided
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CD patients prescribed TYSABRI® within the TOUCH prescribing program Exclusion Criteria:
Both
18 Years and older
No
United States
 
NCT00707512
ELN100226-CD451, CD INFORM
Not Provided
Elan Pharmaceuticals
Elan Pharmaceuticals
Biogen Idec
Not Provided
Elan Pharmaceuticals
March 2012

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