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CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

This study is currently recruiting participants.
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
History of Changes
  Purpose

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)


Condition Intervention
Crohn's Disease
 Drug: Natalizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Natalizumab Through Further Observational Research and Monitoring

Resource links provided by NLM:

Drug Information available for: Natalizumab
U.S. FDA Resources

Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of serious and/or clinically significant infections, malignancies, and other SAEs in patients with CD treated with TYSABRI®

Secondary Outcome Measures:
  • Disease severity over time in CD patients treated with TYSABRI®.

Estimated Enrollment: 2000
Study Start Date: June 2008
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Specialty IBD clinics or GI clinical practices

Criteria

Inclusion Criteria:

  • CD patients prescribed TYSABRI® within the TOUCH prescribing program Exclusion Criteria:
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707512

Locations
United States, West Virginia
United BioSource Corporation Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Contact     888-613-7542     LSKC_CD_INFORM@unitedbiosource.com    
Sponsors and Collaborators
Elan Pharmaceuticals
Biogen Idec
  More Information

No publications provided

Responsible Party: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00707512     History of Changes
Other Study ID Numbers: ELN100226-CD451, CD INFORM
Study First Received: June 27, 2008
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013