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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
  Purpose

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).


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:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2000
Study Start Date: June 2008
Estimated Study Completion Date: August 2050
Estimated Primary Completion Date: August 2050 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Natalizumab
    Administered as specified in the TOUCH Prescribing Program
    Other Names:
    • Tysabri
    • BG00002
Detailed Description:

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.

  Eligibility

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Biogen Idec clinicaltrials@biogenidec.com

  Show 37 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00707512     History of Changes
Other Study ID Numbers: 101CD401, ELN100226-CD451
Study First Received: June 27, 2008
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014