CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

This study is currently recruiting participants.

Verified by Elan Pharmaceuticals, July 2009

First Received: June 27, 2008 Last Updated: July 14, 2009 History of Changes

Sponsor:	Elan Pharmaceuticals
Collaborator:	Biogen Idec
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00707512

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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Cancer Crohn's Disease

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:

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 must be enrolled prior to their 6th infusion of TYSABRI®

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707512

Locations

United States, West Virginia
There may be multiple sites in this clinical trial. Please contact United BioSource Corporation	Recruiting
200 Pinecrest Plaza, 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:	July 14, 2009
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 August 31, 2010