CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
Sponsor
Biogen (Industry)
Overall Status
Terminated
CT.gov ID
NCT00707512
Collaborator
(none)
87
36
506
2.4
0
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
87 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
Study Start Date
:
Jun 1, 2008
Anticipated Primary Completion Date
:
Aug 1, 2050
Anticipated Study Completion Date
:
Aug 1, 2050
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research site | Scottsdale | Arizona | United States | 85260-1315 |
| 2 | Research site | Oceanside | California | United States | 92056-4457 |
| 3 | Research site | San Francisco | California | United States | 94115 |
| 4 | Research site | Hamden | Connecticut | United States | 06518 |
| 5 | Research site | Hartford | Connecticut | United States | 06106-3322 |
| 6 | Research site | Gainesville | Florida | United States | 32610-3003 |
| 7 | Research site | Miami | Florida | United States | 33136 |
| 8 | Research site | Winter Park | Florida | United States | 32789 |
| 9 | Research site | Atlanta | Georgia | United States | 30342-5000 |
| 10 | Research site | Crestview Hills | Kentucky | United States | 41017-3409 |
| 11 | Research site | Lexington | Kentucky | United States | 40536-0298 |
| 12 | Research site | Louisville | Kentucky | United States | 40202 |
| 13 | Research site | Baltimore | Maryland | United States | 21201 |
| 14 | Research site | Boston | Massachusetts | United States | 02114 |
| 15 | Research site | Boston | Massachusetts | United States | 02215 |
| 16 | Research site | Ann Arbor | Michigan | United States | 48109-0361 |
| 17 | Research site | Plymouth | Minnesota | United States | 55446 |
| 18 | Research site | Columbia | Missouri | United States | 65201 |
| 19 | Research site | Lebanon | New Hampshire | United States | 03756 |
| 20 | Research site | Egg Harbour Township | New Jersey | United States | 08234-5857 |
| 21 | Research site | Great Neck | New York | United States | 11021 |
| 22 | Research site | Lake Success | New York | United States | 11042-1008 |
| 23 | Research site | New York | New York | United States | 10021 |
| 24 | Research site | Rochester | New York | United States | 55905 |
| 25 | Research site | Troy | New York | United States | 48084-5435 |
| 26 | Research site | Chapel Hill | North Carolina | United States | 27599-7080 |
| 27 | Research site | Charlotte | North Carolina | United States | 28207 |
| 28 | Research site | Raleigh | North Carolina | United States | 27607-6688 |
| 29 | Research site | Cincinnati | Ohio | United States | 45219 |
| 30 | Research site | Cleveland | Ohio | United States | 44195 |
| 31 | Research site | Providence | Rhode Island | United States | 02904 |
| 32 | Research site | Nashville | Tennessee | United States | 37232 |
| 33 | Research site | Grapevine | Texas | United States | 76051 |
| 34 | Research site | Houston | Texas | United States | 77030 |
| 35 | Research site | Tacoma | Washington | United States | 98405 |
| 36 | Research site | San Juan | Puerto Rico | 00935 |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT00707512
Other Study ID Numbers:
- 101CD401
- ELN100226-CD451
First Posted:
Jul 1, 2008
Last Update Posted:
Jul 20, 2015
Last Verified:
Jun 1, 2015