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
Phase 3
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Crohn's Disease
Both
Crohn's Disease
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Subjects Achieving Clinical Remission
Outcome Description:
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.
Outcome Time Frame:
Week 156
Safety Issue:
No
Principal Investigator
Anne Camez, MD
Investigator Role:
Study Director
Investigator Affiliation:
Abbott
Authority:
United States: Food and Drug Administration
Study ID:
M04-690
NCT ID:
NCT00195715
Start Date:
September 2004
Completion Date:
December 2008
Related Keywords:
- Crohn's Disease
- Crohn Disease
Name | Location |
|---|---|
| Site Ref # / Investigator 1894 | Huntsville, Alabama 35801 |
| Site Ref # / Investigator 1895 | Jacksonville, Alabama 35801 |
| Site Ref # / Investigator 1787 | La Jolla, California 92037 |
| Site Ref # / Investigator 1902 | Roseville, California 95661 |
| Site Ref # / Investigator 1891 | San Diego, California 92123 |
| Site Ref # / Investigator 1824 | San Diego, California 92123 |
| Site Ref # / Investigator 1860 | Englewood, Colorado 80113 |
| Site Ref # / Investigator 6178 | Lone Tree, Colorado 80124 |
| Site Ref # / Investigator 1904 | Wheat Ridge, Colorado 80033 |
| Site Ref # / Investigator 1858 | Bridgeport, Connecticut 06606 |
| Site Ref # / Investigator 1827 | Clearwater, Florida 33765 |
| Site Ref # / Investigator 1883 | Gainesville, Florida 32610 |
| Site Ref # / Investigator 1909 | Hollywood, Florida 33021 |
| Site Ref # / Investigator 1884 | Ormond Beach, Florida 32174 |
| Site Ref # / Investigator 1786 | Winter Park, Florida 32789 |
| Site Ref # / Investigator 1912 | Atlanta, Georgia 30342 |
| Site Ref # / Investigator 1878 | Arlington Heights, Illinois 60005 |
| Site Ref # / Investigator 2534 | Chicago, Illinois 60637 |
| Site Ref # / Investigator 1823 | Peoria, Illinois 61602 |
| Site Ref # / Investigator 1885 | Anderson, Indiana 46016 |
| Site Ref # / Investigator 1890 | Indianapolis, Indiana 46237 |
| Site Ref # / Investigator 1900 | Indianapolis, Indiana 46202 |
| Site Ref # / Investigator 1892 | Lexington, Kentucky 40536 |
| Site Ref # / Investigator 1906 | Metairie, Louisiana 70006 |
| Site Ref # / Investigator 1881 | Annapolis, Maryland 24101 |
| Site Ref # / Investigator 1829 | Chevy Chase, Maryland 20815 |
| Site Ref # / Investigator 1782 | Lutherville, Maryland 21093 |
| Site Ref # / Investigator 1887 | Silver Spring, Maryland 20901 |
| Site Ref # / Investigator 2602 | Worcester, Massachusetts 01610 |
| Site Ref # / Investigator 1773 | Plymouth, Minnesota 55446 |
| Site Ref # / Investigator 1856 | Rochester, Minnesota 55905 |
| Site Ref # / Investigator 1832 | Jackson, Mississippi 39202 |
| Site Ref # / Investigator 1880 | Kansas City, Missouri 64131 |
| Site Ref # / Investigator 1853 | Mexico, Missouri 65265 |
| Site Ref # / Investigator 1862 | St. Louis, Missouri 63128 |
| Site Ref # / Investigator 1888 | St. Louis, Missouri 63110 |
| Site Ref # / Investigator 1901 | Egg Harbor Township, New Jersey 08234 |
| Site Ref # / Investigator 1825 | Great Neck, New York 11021 |
| Site Ref # / Investigator 1848 | Lake Success, New York 11042 |
| Site Ref # / Investigator 1841 | New York, New York 10028 |
| Site Ref # / Investigator 1852 | Asheville, North Carolina 28801 |
| Site Ref # / Investigator 1882 | Charlote, North Carolina 28211 |
| Site Ref # / Investigator 1855 | Charlotte, North Carolina 28207 |
| Site Ref # / Investigator 1911 | Raleigh, North Carolina 27612 |
| Site Ref # / Investigator 1861 | Wilmington, North Carolina 28403 |
| Site Ref # / Investigator 1784 | Beachwood, Ohio 44122 |
| Site Ref # / Investigator 1896 | Beaver Creek, Ohio 45440 |
| Site Ref # / Investigator 1833 | Cincinatti, Ohio 45219 |
| Site Ref # / Investigator 1826 | Cleveland, Ohio 44106-5066 |
| Site Ref # / Investigator 1822 | Portland, Oregon 97220 |
| Site Ref # / Investigator 1886 | Pittsburgh, Pennsylvania 15216 |
| Site Ref # / Investigator 1905 | Columbia, South Carolina 29204 |
| Site Ref # / Investigator 1769 | Germantown, Tennessee 38138 |
| Site Ref # / Investigator 1907 | Nashville, Tennessee 37205 |
| Site Ref # / Investigator 1963 | Nashville, Tennessee 37232 |
| Site Ref # / Investigator 1899 | Round Rock, Texas 78681 |
| Site Ref # / Investigator 1903 | Salt Lake City, Utah 84107 |
| Site Ref # / Investigator 6180 | Charlottesville, Virginia 22911 |
| Site Ref # / Investigator 1783 | Danville, Virginia 24541 |
| Site Ref # / Investigator 1897 | Norfolk, Virginia 23502 |
| Site Ref # / Investigator 1850 | Spokane, Washington 99204 |
| Site Ref # / Investigator 1831 | Milwaukee, Wisconsin 53215 |
| Site Ref # / Investigator 1849 | West Bend, Wisconsin 53095 |
