Study Stopped
Sponsor's decision.
CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
INFORM
INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
2 other identifiers
observational
87
2 countries
36
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2008
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2008
CompletedStudy Start
First participant enrolled
June 30, 2008
CompletedFirst Posted
Study publicly available on registry
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2015
CompletedJune 3, 2024
May 1, 2024
6.9 years
June 27, 2008
May 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Administered as specified in the TOUCH Prescribing Program
Eligibility Criteria
Participants with CD who were naĂ¯ve to natalizumab treatment and participants with CD who have been previously treated with natalizumab.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (36)
Research site
Scottsdale, Arizona, 85260, United States
Research site
Oceanside, California, 92056, United States
Research site
San Francisco, California, 94115, United States
Research site
Hamden, Connecticut, 06518, United States
Research site
Hartford, Connecticut, 06106, United States
Research site
Gainesville, Florida, 32610, United States
Research site
Miami, Florida, 33136, United States
Research site
Winter Park, Florida, 32789, United States
Research site
Atlanta, Georgia, 30342, United States
Research site
Crestview Hills, Kentucky, 41017, United States
Research site
Lexington, Kentucky, 40536, United States
Research site
Louisville, Kentucky, 40202, United States
Research site
Baltimore, Maryland, 21201, United States
Research site
Boston, Massachusetts, 02114, United States
Research site
Boston, Massachusetts, 02215, United States
Research site
Ann Arbor, Michigan, 48109, United States
Research site
Plymouth, Minnesota, 55446, United States
Research site
Columbia, Missouri, 65201, United States
Research site
Lebanon, New Hampshire, 03756, United States
Research site
Egg Harbor, New Jersey, 08234, United States
Research site
Great Neck, New York, 11021, United States
Research site
Lake Success, New York, 11042, United States
Research site
New York, New York, 10021, United States
Research site
Rochester, New York, 55905, United States
Research site
Troy, New York, 48084, United States
Research site
Chapel Hill, North Carolina, 27599, United States
Research site
Charlotte, North Carolina, 28207, United States
Research site
Raleigh, North Carolina, 27607, United States
Research site
Cincinnati, Ohio, 45219, United States
Research site
Cleveland, Ohio, 44195, United States
Research site
Providence, Rhode Island, 02904, United States
Research site
Nashville, Tennessee, 37232, United States
Research site
Grapevine, Texas, 76051, United States
Research site
Houston, Texas, 77030, United States
Research site
Tacoma, Washington, 98405, United States
Research site
San Juan, 00935, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 1, 2008
Study Start
June 30, 2008
Primary Completion
May 28, 2015
Study Completion
May 28, 2015
Last Updated
June 3, 2024
Record last verified: 2024-05