Crohn's Disease Clinical Trial
Official title:
A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease
| Verified date | July 2011 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.
| Status | Completed |
| Enrollment | 777 |
| Est. completion date | December 2008 |
| Est. primary completion date | March 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study - Diagnosis of Crohn's disease - Willing and able to give informed consent Exclusion Criteria: - Diagnosis of ulcerative colitis - Women cannot be pregnant or breastfeeding - Previous history of listeria infection or untreated tuberculosis - Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Site Ref # / Investigator 1940 | Bedford Park | South Australia |
| Australia | Site Ref # / Investigator 1935 | Box Hill | Victoria |
| Australia | Site Ref # / Investigator 1938 | Camperdown | New South Wales |
| Australia | Site Ref # / Investigator 1937 | Parkville | Victoria |
| Belgium | Site Ref # / Investigator 1941 | Bonheiden | |
| Belgium | Site Ref # / Investigator 5189 | Brussels | |
| Belgium | Site Ref # / Investigator 2535 | Leuven | |
| Canada | Site Ref # / Investigator 1868 | Calgary | Alberta |
| Canada | Site Ref # / Investigator 1924 | Edmonton | Alberta |
| Canada | Site Ref # / Investigator 426 | Edmonton | Alberta |
| Canada | Site Ref # / Investigator 1873 | Halifax | Nova Scotia |
| Canada | Site Ref # / Investigator 1876 | Hamilton | Ontario |
| Canada | Site Ref # / Investigator 1875 | London | Ontario |
| Canada | Site Ref # / Investigator 1866 | Montreal | Quebec |
| Canada | Site Ref # / Investigator 2459 | Montreal | Quebec |
| Canada | Site Ref # / Investigator 1863 | Quebec City | Quebec |
| Canada | Site Ref # / Investigator 1772 | Toronto | Ontario |
| Canada | Site Ref # / Investigator 1865 | Toronto | Ontario |
| Canada | Site Ref # / Investigator 1872 | Vancouver | British Columbia |
| Canada | Site Ref # / Investigator 1914 | Vancouver | British Columbia |
| Canada | Site Ref # / Investigator 1870 | Victoria | British Columbia |
| Canada | Site Ref # / Investigator 1874 | Winnipeg | Manitoba |
| Denmark | Site Ref # / Investigator 1952 | Arhus C | |
| Denmark | Site Ref # / Investigator 1922 | Odense C | |
| France | Site Ref # / Investigator 1964 | Amiens | |
| France | Site Ref # / Investigator 2458 | Lillie Cedex | |
| France | Site Ref # / Investigator 1913 | Paris | |
| Germany | Site Ref # / Investigator 1942 | Kiel | |
| Germany | Site Ref # / Investigator 2524 | Regensburg | |
| Germany | Site Ref # / Investigator 1943 | Stuttgart | |
| Hungary | Site Ref # / Investigator 1944 | Budapest | |
| Hungary | Site Ref # / Investigator 1916 | Szekszard | |
| Italy | Site Ref # / Investigator 342 | Bologna | |
| Italy | Site Ref # / Investigator 1945 | Rome | |
| Italy | Site Ref # / Investigator 1779 | Turin | |
| Netherlands | Site Ref # / Investigator 1919 | Amsterdam | |
| Netherlands | Site Ref # / Investigator 1946 | Heerlen | |
| Poland | Site Ref # / Investigator 1948 | Szczecin | 71-252 |
| Poland | Site Ref # / Investigator 1947 | Warsaw | |
| South Africa | Site Ref # / Investigator 1763 | Cape Town | WC |
| South Africa | Site Ref # / Investigator 1846 | Durban | NL |
| South Africa | Site Ref # / Investigator 1844 | Johannesburg | GT |
| Spain | Site Ref # / Investigator 341 | Madrid | |
| Spain | Site Ref # / Investigator 2457 | Puerto de Sagunto | |
| Sweden | Site Ref # / Investigator 1949 | Gothenburg | |
| Sweden | Site Ref # / Investigator 1778 | Stockholm | |
| United Kingdom | Site Ref # / Investigator 1951 | Edinburgh | |
| United Kingdom | Site Ref # / Investigator 1771 | Rotherham | |
| United States | Site Ref # / Investigator 1885 | Anderson | Indiana |
| United States | Site Ref # / Investigator 1881 | Annapolis | Maryland |
| United States | Site Ref # / Investigator 1878 | Arlington Heights | Illinois |
| United States | Site Ref # / Investigator 1852 | Asheville | North Carolina |
| United States | Site Ref # / Investigator 1912 | Atlanta | Georgia |
| United States | Site Ref # / Investigator 1784 | Beachwood | Ohio |
| United States | Site Ref # / Investigator 1896 | Beaver Creek | Ohio |
| United States | Site Ref # / Investigator 1858 | Bridgeport | Connecticut |
| United States | Site Ref # / Investigator 1882 | Charlote | North Carolina |
| United States | Site Ref # / Investigator 1855 | Charlotte | North Carolina |
| United States | Site Ref # / Investigator 6180 | Charlottesville | Virginia |
| United States | Site Ref # / Investigator 1829 | Chevy Chase | Maryland |
| United States | Site Ref # / Investigator 2534 | Chicago | Illinois |
| United States | Site Ref # / Investigator 1833 | Cincinatti | Ohio |
| United States | Site Ref # / Investigator 1827 | Clearwater | Florida |
| United States | Site Ref # / Investigator 1826 | Cleveland | Ohio |
| United States | Site Ref # / Investigator 1905 | Columbia | South Carolina |
| United States | Site Ref # / Investigator 1783 | Danville | Virginia |
| United States | Site Ref # / Investigator 1901 | Egg Harbor Township | New Jersey |
| United States | Site Ref # / Investigator 1860 | Englewood | Colorado |
| United States | Site Ref # / Investigator 1883 | Gainesville | Florida |
| United States | Site Ref # / Investigator 1769 | Germantown | Tennessee |
| United States | Site Ref # / Investigator 1825 | Great Neck | New York |
| United States | Site Ref # / Investigator 1909 | Hollywood | Florida |
| United States | Site Ref # / Investigator 1894 | Huntsville | Alabama |
| United States | Site Ref # / Investigator 1890 | Indianapolis | Indiana |
| United States | Site Ref # / Investigator 1900 | Indianapolis | Indiana |
| United States | Site Ref # / Investigator 1832 | Jackson | Mississippi |
| United States | Site Ref # / Investigator 1895 | Jacksonville | Alabama |
| United States | Site Ref # / Investigator 1880 | Kansas City | Missouri |
| United States | Site Ref # / Investigator 1787 | La Jolla | California |
| United States | Site Ref # / Investigator 1848 | Lake Success | New York |
| United States | Site Ref # / Investigator 1892 | Lexington | Kentucky |
| United States | Site Ref # / Investigator 6178 | Lone Tree | Colorado |
| United States | Site Ref # / Investigator 1782 | Lutherville | Maryland |
| United States | Site Ref # / Investigator 1906 | Metairie | Louisiana |
| United States | Site Ref # / Investigator 1853 | Mexico | Missouri |
| United States | Site Ref # / Investigator 1831 | Milwaukee | Wisconsin |
| United States | Site Ref # / Investigator 1907 | Nashville | Tennessee |
| United States | Site Ref # / Investigator 1963 | Nashville | Tennessee |
| United States | Site Ref # / Investigator 1841 | New York | New York |
| United States | Site Ref # / Investigator 1897 | Norfolk | Virginia |
| United States | Site Ref # / Investigator 1884 | Ormond Beach | Florida |
| United States | Site Ref # / Investigator 1823 | Peoria | Illinois |
| United States | Site Ref # / Investigator 1886 | Pittsburgh | Pennsylvania |
| United States | Site Ref # / Investigator 1773 | Plymouth | Minnesota |
| United States | Site Ref # / Investigator 1822 | Portland | Oregon |
| United States | Site Ref # / Investigator 1911 | Raleigh | North Carolina |
| United States | Site Ref # / Investigator 1856 | Rochester | Minnesota |
| United States | Site Ref # / Investigator 1902 | Roseville | California |
| United States | Site Ref # / Investigator 1899 | Round Rock | Texas |
| United States | Site Ref # / Investigator 1903 | Salt Lake City | Utah |
| United States | Site Ref # / Investigator 1824 | San Diego | California |
| United States | Site Ref # / Investigator 1891 | San Diego | California |
| United States | Site Ref # / Investigator 1887 | Silver Spring | Maryland |
| United States | Site Ref # / Investigator 1850 | Spokane | Washington |
| United States | Site Ref # / Investigator 1862 | St. Louis | Missouri |
| United States | Site Ref # / Investigator 1888 | St. Louis | Missouri |
| United States | Site Ref # / Investigator 1849 | West Bend | Wisconsin |
| United States | Site Ref # / Investigator 1904 | Wheat Ridge | Colorado |
| United States | Site Ref # / Investigator 1861 | Wilmington | North Carolina |
| United States | Site Ref # / Investigator 1786 | Winter Park | Florida |
| United States | Site Ref # / Investigator 2602 | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States, Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving Clinical Remission | Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity. | Week 156 | No |
| Secondary | Percentage of Subjects Achieving Clinical Remission | Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity. | Week 48 | No |
| Secondary | Percentage of Subjects Achieving Clinical Remission | Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity. | Week 108 | No |
| Secondary | Percentage of Subjects Achieving Clinical Remission | Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity. | Week 204 | No |
| Secondary | Percentage of Subjects Achieving Clinical Response 100 (CR-100) | A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity. | Week 156 | No |
| Secondary | Percentage of Subjects Achieving Clinical Response 70 (CR-70) | A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity. | Week 156 | No |
| Secondary | Percentage of Subjects Achieving Steroid-free Clinical Remission | Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity. | Week 156 | No |
| Secondary | Percentage of Subjects Achieving Steroid-free CR-100 | Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity. | Week 156 | No |
| Secondary | Percentage of Subjects With Fistula Remission | Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit. | Week 156 | No |
| Secondary | Percentage of Subjects With Infection | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Serious Infection | Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens. | Up to 262 weeks of adalimumab treatment | Yes |
| Secondary | Percentage of Subjects With Malignancy | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Lymphoma | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Nonmelanoma Skin Cancer | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma) | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer) | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Injection Site Reaction-related Adverse Event | An injection site reaction is any adverse event corresponding to a preferred term beginning with "injection site" excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration. | Up to 262 weeks of adalimumab treatment | Yes |
| Secondary | Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis) | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Congestive Heart Failure | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Demyelinating Disease | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Hepatic-related Adverse Event | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Allergic Reaction-related Adverse Event | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Lupus-like Syndrome | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Hematologic-related Adverse Event | Up to 262 weeks of adalimumab treatment | Yes | |
| Secondary | Percentage of Subjects With Fatal Adverse Event | Up to 262 weeks of adalimumab treatment | Yes |
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