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| ID | Type | Description | Link |
|---|---|---|---|
| ELN100226-CD451 | Other Identifier | Elan Pharmaceuticals |
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Sponsor's decision.
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natalizumab | Drug | Administered as specified in the TOUCH Prescribing Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Key Inclusion Criteria:
Key Exclusion criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
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Participants with CD who were naïve to natalizumab treatment and participants with CD who have been previously treated with natalizumab.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Scottsdale | Arizona | 85260 | United States | ||
| Research site |
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| 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 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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