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| ID | Type | Description | Link |
|---|---|---|---|
| C0168T45 | Other Identifier | Centocor, Inc |
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| Name | Class |
|---|---|
| Centocor BV | INDUSTRY |
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This is a study evaluating the long-term safety of infliximab (Remicade)
The purpose of this study is to collect long-term safety information on infliximab (Remicade) from patients who participate in research studies using those drugs. All patients in these studies are being asked to participate in this long-term safety follow-up study which will provide important information about the study drug. The long-term effect of the study drug on survival, serious infections, new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period. Additional information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if you received infliximab (Remicade) after the end of the primary study. Study participation in this research study is 5 years after the end of the primary study. Questionnaires will be completed about patient's health and the occurrence of these safety events at intervals of 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after patients complete participation in the primary study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in infliximab clinical studies | All patients enrolled in selected Centocor sponsored infliximab clinical studies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab (Remicade) | Drug | This is an non-interventional study. Participants took the study product as part of their medical routine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with each of the following long-term safety events | Number of patients with each of the following long-term safety events: serious infections, new malignancies, new autoimmune diseases, death, or delayed hypersensitivity (serum sickness-like) reactions. | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with malignancies by malignancy type | Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies). | Five years |
| Number of patients with serious infections by type of infection |
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Inclusion Criteria:
Exclusion Criteria:
- Did not previously participate in Centocor sponsored infliximab clinical studies.
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All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies.
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Label | URL |
|---|---|
| Study results from the long term safety follow-up of REMICADE (RESULTS) | View source |
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| Five years |
| Huntsville |
| Alabama |
| United States |
| Montgomery | Alabama | United States |
| Paradise Valley | Arizona | United States |
| Phoenix | Arizona | United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| Anaheim | California | United States |
| Fresno | California | United States |
| Irvine | California | United States |
| Los Angeles | California | United States |
| Madera | California | United States |
| Orange | California | United States |
| Pasadena | California | United States |
| Rancho Mirage | California | United States |
| San Diego | California | United States |
| Santa Monica | California | United States |
| Stanford | California | United States |
| Torrance | California | United States |
| Denver | Colorado | United States |
| Hamden | Connecticut | United States |
| Hartford | Connecticut | United States |
| New Haven | Connecticut | United States |
| Waterbury | Connecticut | United States |
| Aventura | Florida | United States |
| Largo | Florida | United States |
| Ocala | Florida | United States |
| Orlando | Florida | United States |
| Palm Harbor | Florida | United States |
| Sarasota | Florida | United States |
| Tampa | Florida | United States |
| Alpharetta | Georgia | United States |
| Atlanta | Georgia | United States |
| Marietta | Georgia | United States |
| Coeur d'Alene | Idaho | United States |
| Chicago | Illinois | United States |
| Evanston | Illinois | United States |
| Gurnee | Illinois | United States |
| Maywood | Illinois | United States |
| Normal | Illinois | United States |
| Rockford | Illinois | United States |
| Springfield | Illinois | United States |
| Indianapolis | Indiana | United States |
| Iowa City | Iowa | United States |
| Overland Park | Kansas | United States |
| Wichita | Kansas | United States |
| Louisville | Kentucky | United States |
| Portland | Maine | United States |
| Baltimore | Maryland | United States |
| Greenbelt | Maryland | United States |
| Wheaton | Maryland | United States |
| Andover | Massachusetts | United States |
| Boston | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Detroti | Michigan | United States |
| East Lansing | Michigan | United States |
| Grand Rapids | Michigan | United States |
| Edina | Minnesota | United States |
| Fridley | Minnesota | United States |
| Jackson | Mississippi | United States |
| St Louis | Missouri | United States |
| Lincoln | Nebraska | United States |
| Reno | Nevada | United States |
| Voorhees Township | New Jersey | United States |
| Manhasset | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Charlotte | North Carolina | United States |
| Durham | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Lake Oswego | Oregon | United States |
| Portland | Oregon | United States |
| Bethlehem | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Norristown | Pennsylvania | United States |
| Philadelphia Pennsylvan | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Willow Grove | Pennsylvania | United States |
| North Charleston | South Carolina | United States |
| Goodlettsville | Tennessee | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Lubbock | Texas | United States |
| San Antonio | Texas | United States |
| Burlington | Vermont | United States |
| Salem | Virginia | United States |
| Bellevue | Washington | United States |
| Kirkland | Washington | United States |
| Seattle | Washington | United States |
| Spokane | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Buenos Aires | Argentina |
| Córdoba | Argentina |
| Cp | Argentina |
| Rosario | Argentina |
| San Miguel de Tucumán | Argentina |
| Graz | Austria |
| Innsbruck | Austria |
| Vienna | Austria |
| Brussels | Belgium |
| Diepenbeek | Belgium |
| Edegem | Belgium |
| Genk | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Richmond | British Columbia | Canada |
| Vancouver | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Moncton | New Brunswick | Canada |
| St. John's | Newfoundland and Labrador | Canada |
| Halifax | Nova Scotia | Canada |
| Hamilton | Ontario | Canada |
| Kitchener | Ontario | Canada |
| London | Ontario | Canada |
| Markham | Ontario | Canada |
| Newmarket | Ontario | Canada |
| North Bay | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Waterloo | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Sainte-Foy | Quebec | Canada |
| Sherbrooke | Quebec | Canada |
| Ste-Foy | Quebec | Canada |
| Halifax | Canada |
| Hamilton Ontario | Canada |
| Montreal | Canada |
| Saskatoon | Canada |
| Aarhus | Denmark |
| Hellerup | Denmark |
| Hvidovre | Denmark |
| København NV | Denmark |
| Odense | Denmark |
| Helsinki | Finland |
| Hus | Finland |
| Jyväskylä | Finland |
| Pikonlinna | Finland |
| Créteil | France |
| Montpellier | France |
| Nantes | France |
| Nice | France |
| Paris | France |
| Pierre-Bénite | France |
| Poitiers | France |
| Berlin | Germany |
| Bochum | Germany |
| Cologne | Germany |
| Dresden | Germany |
| Erlangen | Germany |
| Frankfurt | Germany |
| Hamburg | Germany |
| Leipzig | Germany |
| Mainz | Germany |
| Münster | Germany |
| Oldenburg | Germany |
| Würzburg | Germany |
| Wÿrzburg | Germany |
| Budapest | Hungary |
| Debrecen | Hungary |
| Dublin | Ireland |
| Haifa | Israel |
| Tel Aviv | Israel |
| Amsterdam-Zuidoost | Netherlands |
| Maastricht | Netherlands |
| Rotterdam | Netherlands |
| Utrecht | Netherlands |
| Oslo | Norway |
| Bialystok | Poland |
| Lublin | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Włoszczowa | Poland |
| Barcelona | Spain |
| Buenos Aires | Spain |
| Córdoba | Spain |
| Federal | Spain |
| Madrid | Spain |
| Gothenburg | Sweden |
| Geneva | Switzerland |
| Zurich | Switzerland |
| Bath | United Kingdom |
| Birmingham | United Kingdom |
| Cambridge | United Kingdom |
| Cannock | United Kingdom |
| Leeds | United Kingdom |
| Liverpool | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Norwich | United Kingdom |
| Oxford | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D003424 | Crohn Disease |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| 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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