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NCT00707512 Clinical Trial

CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Crohn's Disease Clinical Trial

— INFORM  

Official title:
INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00707512
Other study ID # 101CD401
Secondary ID ELN100226-CD451
Status Terminated
Phase
First received
Last updated
Start date June 30, 2008
Est. completion date May 28, 2015

Study information
Verified date May 2024
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of the study is to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse event (SAE) in participants with Crohn's Disease (CD) treated with natalizumab. The secondary objective of this study in this study population is to evaluate disease severity over time in participants with CD treated with natalizumab based on changes in the Harvey-Bradshaw Index (HBI).

Description:

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

Recruitment information / eligibility
Status Terminated
Enrollment 87
Est. completion date May 28, 2015
Est. primary completion date May 28, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Tysabri Outreach Unified Commitment to Health (TOUCH) Prescribing Program. Key Exclusion criteria: - None Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• natalizumab
Administered as specified in the TOUCH Prescribing Program

Locations
Country Name City State
Puerto Rico Research site San Juan
United States Research site Ann Arbor Michigan
United States Research site Atlanta Georgia
United States Research site Baltimore Maryland
United States Research site Boston Massachusetts
United States Research site Boston Massachusetts
United States Research site Chapel Hill North Carolina
United States Research site Charlotte North Carolina
United States Research site Cincinnati Ohio
United States Research site Cleveland Ohio
United States Research site Columbia Missouri
United States Research site Crestview Hills Kentucky
United States Research site Egg Harbor Township New Jersey
United States Research site Gainesville Florida
United States Research site Grapevine Texas
United States Research site Great Neck New York
United States Research site Hamden Connecticut
United States Research site Hartford Connecticut
United States Research site Houston Texas
United States Research site Lake Success New York
United States Research site Lebanon New Hampshire
United States Research site Lexington Kentucky
United States Research site Louisville Kentucky
United States Research site Miami Florida
United States Research site Nashville Tennessee
United States Research site New York New York
United States Research site Oceanside California
United States Research site Plymouth Minnesota
United States Research site Providence Rhode Island
United States Research site Raleigh North Carolina
United States Research site Rochester New York
United States Research site San Francisco California
United States Research site Scottsdale Arizona
United States Research site Tacoma Washington
United States Research site Troy New York
United States Research site Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab Every 6 months for up to 5 years following the first Tysabri infusion
Secondary Measurement of disease severity over time as assessed by change in HBI Every 6 months for up to 5 years following the first Tysabri infusion
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