Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
NCT ID: NCT00195715
Last Updated: 2011-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
777 participants
INTERVENTIONAL
2004-09-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Adalimumab
Adalimumab 40 mg by subcutaneous injection every other week or every week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Crohn's disease
* Willing and able to give informed consent
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Anne Camez, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Ref # / Investigator 1894
Huntsville, Alabama, United States
Site Ref # / Investigator 1895
Jacksonville, Alabama, United States
Site Ref # / Investigator 1787
La Jolla, California, United States
Site Ref # / Investigator 1902
Roseville, California, United States
Site Ref # / Investigator 1824
San Diego, California, United States
Site Ref # / Investigator 1891
San Diego, California, United States
Site Ref # / Investigator 1860
Englewood, Colorado, United States
Site Ref # / Investigator 6178
Lone Tree, Colorado, United States
Site Ref # / Investigator 1904
Wheat Ridge, Colorado, United States
Site Ref # / Investigator 1858
Bridgeport, Connecticut, United States
Site Ref # / Investigator 1827
Clearwater, Florida, United States
Site Ref # / Investigator 1883
Gainesville, Florida, United States
Site Ref # / Investigator 1909
Hollywood, Florida, United States
Site Ref # / Investigator 1884
Ormond Beach, Florida, United States
Site Ref # / Investigator 1786
Winter Park, Florida, United States
Site Ref # / Investigator 1912
Atlanta, Georgia, United States
Site Ref # / Investigator 1878
Arlington Heights, Illinois, United States
Site Ref # / Investigator 2534
Chicago, Illinois, United States
Site Ref # / Investigator 1823
Peoria, Illinois, United States
Site Ref # / Investigator 1885
Anderson, Indiana, United States
Site Ref # / Investigator 1900
Indianapolis, Indiana, United States
Site Ref # / Investigator 1890
Indianapolis, Indiana, United States
Site Ref # / Investigator 1892
Lexington, Kentucky, United States
Site Ref # / Investigator 1906
Metairie, Louisiana, United States
Site Ref # / Investigator 1881
Annapolis, Maryland, United States
Site Ref # / Investigator 1829
Chevy Chase, Maryland, United States
Site Ref # / Investigator 1782
Lutherville, Maryland, United States
Site Ref # / Investigator 1887
Silver Spring, Maryland, United States
Site Ref # / Investigator 2602
Worcester, Massachusetts, United States
Site Ref # / Investigator 1773
Plymouth, Minnesota, United States
Site Ref # / Investigator 1856
Rochester, Minnesota, United States
Site Ref # / Investigator 1832
Jackson, Mississippi, United States
Site Ref # / Investigator 1880
Kansas City, Missouri, United States
Site Ref # / Investigator 1853
Mexico, Missouri, United States
Site Ref # / Investigator 1888
St Louis, Missouri, United States
Site Ref # / Investigator 1862
St Louis, Missouri, United States
Site Ref # / Investigator 1901
Egg Harbor, New Jersey, United States
Site Ref # / Investigator 1825
Great Neck, New York, United States
Site Ref # / Investigator 1848
Lake Success, New York, United States
Site Ref # / Investigator 1841
New York, New York, United States
Site Ref # / Investigator 1852
Asheville, North Carolina, United States
Site Ref # / Investigator 1882
Charlote, North Carolina, United States
Site Ref # / Investigator 1855
Charlotte, North Carolina, United States
Site Ref # / Investigator 1911
Raleigh, North Carolina, United States
Site Ref # / Investigator 1861
Wilmington, North Carolina, United States
Site Ref # / Investigator 1784
Beachwood, Ohio, United States
Site Ref # / Investigator 1896
Beavercreek, Ohio, United States
Site Ref # / Investigator 1833
Cincinnati, Ohio, United States
Site Ref # / Investigator 1826
Cleveland, Ohio, United States
Site Ref # / Investigator 1822
Portland, Oregon, United States
Site Ref # / Investigator 1886
Pittsburgh, Pennsylvania, United States
Site Ref # / Investigator 1905
Columbia, South Carolina, United States
Site Ref # / Investigator 1769
Germantown, Tennessee, United States
Site Ref # / Investigator 1907
Nashville, Tennessee, United States
Site Ref # / Investigator 1963
Nashville, Tennessee, United States
Site Ref # / Investigator 1899
Round Rock, Texas, United States
Site Ref # / Investigator 1903
Salt Lake City, Utah, United States
Site Ref # / Investigator 6180
Charlottesville, Virginia, United States
Site Ref # / Investigator 1783
Danville, Virginia, United States
Site Ref # / Investigator 1897
Norfolk, Virginia, United States
Site Ref # / Investigator 1850
Spokane, Washington, United States
Site Ref # / Investigator 1831
Milwaukee, Wisconsin, United States
Site Ref # / Investigator 1849
West Bend, Wisconsin, United States
Site Ref # / Investigator 1938
Camperdown, New South Wales, Australia
Site Ref # / Investigator 1940
Bedford Park, South Australia, Australia
Site Ref # / Investigator 1935
Box Hill, Victoria, Australia
Site Ref # / Investigator 1937
Parkville, Victoria, Australia
Site Ref # / Investigator 1941
Bonheiden, , Belgium
Site Ref # / Investigator 5189
Brussels, , Belgium
Site Ref # / Investigator 2535
Leuven, , Belgium
Site Ref # / Investigator 1868
Calgary, Alberta, Canada
Site Ref # / Investigator 1924
Edmonton, Alberta, Canada
Site Ref # / Investigator 426
Edmonton, Alberta, Canada
Site Ref # / Investigator 1914
Vancouver, British Columbia, Canada
Site Ref # / Investigator 1872
Vancouver, British Columbia, Canada
Site Ref # / Investigator 1870
Victoria, British Columbia, Canada
Site Ref # / Investigator 1874
Winnipeg, Manitoba, 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 1772
Toronto, Ontario, Canada
Site Ref # / Investigator 1865
Toronto, Ontario, Canada
Site Ref # / Investigator 2459
Montreal, Quebec, Canada
Site Ref # / Investigator 1866
Montreal, Quebec, Canada
Site Ref # / Investigator 1863
Québec, Quebec, Canada
Site Ref # / Investigator 1952
Arhus C, , Denmark
Site Ref # / Investigator 1922
Odense C, , Denmark
Site Ref # / Investigator 1964
Amiens, , France
Site Ref # / Investigator 2458
Lillie Cedex, , France
Site Ref # / Investigator 1913
Paris, , France
Site Ref # / Investigator 1942
Kiel, , Germany
Site Ref # / Investigator 2524
Regensburg, , Germany
Site Ref # / Investigator 1943
Stuttgart, , Germany
Site Ref # / Investigator 1944
Budapest, , Hungary
Site Ref # / Investigator 1916
Szekszárd, , Hungary
Site Ref # / Investigator 342
Bologna, , Italy
Site Ref # / Investigator 1945
Rome, , Italy
Site Ref # / Investigator 1779
Turin, , Italy
Site Ref # / Investigator 1919
Amsterdam, , Netherlands
Site Ref # / Investigator 1946
Heerlen, , Netherlands
Site Ref # / Investigator 1948
Szczecin, 71-252, Poland
Site Ref # / Investigator 1947
Warsaw, , Poland
Site Ref # / Investigator 1844
Johannesburg, GT, South Africa
Site Ref # / Investigator 1846
Durban, NL, South Africa
Site Ref # / Investigator 1763
Cape Town, WC, South Africa
Site Ref # / Investigator 341
Madrid, , Spain
Site Ref # / Investigator 2457
Port de Sagunt, , Spain
Site Ref # / Investigator 1949
Gothenburg, , Sweden
Site Ref # / Investigator 1778
Stockholm, , Sweden
Site Ref # / Investigator 1951
Edinburgh, , United Kingdom
Site Ref # / Investigator 1771
Rotherham, , United Kingdom
Countries
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References
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Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.
Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6.
Other Identifiers
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M04-690
Identifier Type: -
Identifier Source: org_study_id
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