Clinical trial NCT00707512: CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
Official title: INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with CD who were naïve to natalizumab treatment and participants with CD who have been previously treated with natalizumab.

Brief 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).

Detailed 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.

Eligibility 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 Tysabri Outreach Unified Commitment to Health (TOUCH) Prescribing Program.

Key Exclusion criteria:

* None

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Primary outcomes:
measure: Rate of serious and/or clinically significant infections, malignancies, and other SAEs in participants with Crohn's Disease treated with natalizumab
timeFrame: Every 6 months for up to 5 years following the first Tysabri infusion
Secondary outcomes:
measure: Measurement of disease severity over time as assessed by change in HBI
timeFrame: Every 6 months for up to 5 years following the first Tysabri infusion
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research site
state: Arizona
city: Oceanside
country: United States
facility: Research site
state: California
city: San Francisco
country: United States
facility: Research site
state: California
city: Hamden
country: United States
facility: Research site
state: Connecticut
city: Hartford
country: United States
facility: Research site
state: Connecticut
city: Gainesville
country: United States
facility: Research site
state: Florida
city: Miami
country: United States
facility: Research site
state: Florida
city: Winter Park
country: United States
facility: Research site
state: Florida
city: Atlanta
country: United States
facility: Research site
state: Georgia
city: Crestview Hills
country: United States
facility: Research site
state: Kentucky
city: Lexington
country: United States
facility: Research site
state: Kentucky
city: Louisville
country: United States
facility: Research site
state: Kentucky
city: Baltimore
country: United States
facility: Research site
state: Maryland
city: Boston
country: United States
facility: Research site
state: Massachusetts
city: Boston
country: United States
facility: Research site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research site
state: Michigan
city: Plymouth
country: United States
facility: Research site
state: Minnesota
city: Columbia
country: United States
facility: Research site
state: Missouri
city: Lebanon
country: United States
facility: Research site
state: New Hampshire
city: Egg Harbor Township
country: United States
facility: Research site
state: New Jersey
city: Great Neck
country: United States
facility: Research site
state: New York
city: Lake Success
country: United States
facility: Research site
state: New York
city: New York
country: United States
facility: Research site
state: New York
city: Rochester
country: United States
facility: Research site
state: New York
city: Troy
country: United States
facility: Research site
state: New York
city: Chapel Hill
country: United States
facility: Research site
state: North Carolina
city: Charlotte
country: United States
facility: Research site
state: North Carolina
city: Raleigh
country: United States
facility: Research site
state: North Carolina
city: Cincinnati
country: United States
facility: Research site
state: Ohio
city: Cleveland
country: United States
facility: Research site
state: Ohio
city: Providence
country: United States
facility: Research site
state: Rhode Island
city: Nashville
country: United States
facility: Research site
state: Tennessee
city: Grapevine
country: United States
facility: Research site
state: Texas
city: Houston
country: United States
facility: Research site
state: Texas
city: Tacoma
country: United States
facility: Research site
state: Washington
city: San Juan
country: Puerto Rico
facility: Research site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: