Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

Phase 3

Completed

Conditions: Crohn's Disease

Registration Number: NCT00195715

Lead Sponsor: Abbott

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 777

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving Clinical Remission	Week 156	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving Clinical Remission	Week 204	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.
Percentage of Subjects Achieving Clinical Response 100 (CR-100)	Week 156	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.
Percentage of Subjects Achieving Clinical Response 70 (CR-70)	Week 156	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.
Percentage of Subjects Achieving Steroid-free Clinical Remission	Week 156	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.
Percentage of Subjects Achieving Steroid-free CR-100	Week 156	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.
Percentage of Subjects With Fistula Remission	Week 156	Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.
Percentage of Subjects With Infection	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Serious Infection	Up to 262 weeks of adalimumab treatment	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.
Percentage of Subjects With Malignancy	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Lymphoma	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Nonmelanoma Skin Cancer	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Injection Site Reaction-related Adverse Event	Up to 262 weeks of adalimumab treatment	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.
Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Congestive Heart Failure	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Demyelinating Disease	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Hepatic-related Adverse Event	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Allergic Reaction-related Adverse Event	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Lupus-like Syndrome	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Hematologic-related Adverse Event	Up to 262 weeks of adalimumab treatment
Percentage of Subjects With Fatal Adverse Event	Up to 262 weeks of adalimumab treatment

Trial Locations

Locations (111): Site Ref # / Investigator 1881
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Annapolis, Maryland, United States
Site Ref # / Investigator 1878
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Arlington Heights, Illinois, United States
Site Ref # / Investigator 1827
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Clearwater, Florida, United States
Site Ref # / Investigator 1786
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Winter Park, Florida, United States
Site Ref # / Investigator 1772
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Toronto, Ontario, Canada
Site Ref # / Investigator 1826
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Cleveland, Ohio, United States
Site Ref # / Investigator 2534
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Chicago, Illinois, United States
Site Ref # / Investigator 1886
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Pittsburgh, Pennsylvania, United States
Site Ref # / Investigator 1924
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Edmonton, Alberta, Canada
Site Ref # / Investigator 5189
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Brussels, Belgium
Site Ref # / Investigator 2535
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Leuven, Belgium
Site Ref # / Investigator 2459
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Montreal, Quebec, Canada
Site Ref # / Investigator 1863
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Quebec City, Quebec, Canada
Site Ref # / Investigator 1906
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Metairie, Louisiana, United States
Site Ref # / Investigator 1858
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Bridgeport, Connecticut, United States
Site Ref # / Investigator 1832
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Jackson, Mississippi, United States
Site Ref # / Investigator 1937
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Parkville, Victoria, Australia
Site Ref # / Investigator 1914
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Vancouver, British Columbia, Canada
Site Ref # / Investigator 1952
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Arhus C, Denmark
Site Ref # / Investigator 1922
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Odense C, Denmark
Site Ref # / Investigator 1822
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Portland, Oregon, United States
Site Ref # / Investigator 1963
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Nashville, Tennessee, United States
Site Ref # / Investigator 1824
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San Diego, California, United States
Site Ref # / Investigator 1900
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Indianapolis, Indiana, United States
Site Ref # / Investigator 1856
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Rochester, Minnesota, United States
Site Ref # / Investigator 1903
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Salt Lake City, Utah, United States
Site Ref # / Investigator 1895
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Jacksonville, Alabama, United States
Site Ref # / Investigator 1829
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Chevy Chase, Maryland, United States
Site Ref # / Investigator 1901
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Egg Harbor Township, New Jersey, United States
Site Ref # / Investigator 1852
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Asheville, North Carolina, United States
Site Ref # / Investigator 1907
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Nashville, Tennessee, United States
Site Ref # / Investigator 342
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Bologna, Italy
Site Ref # / Investigator 1779
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Turin, Italy
Site Ref # / Investigator 2458
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Lillie Cedex, France
Site Ref # / Investigator 1763
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Cape Town, WC, South Africa
Site Ref # / Investigator 2457
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Puerto de Sagunto, Spain
Site Ref # / Investigator 1944
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Budapest, Hungary
Site Ref # / Investigator 1943
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Stuttgart, Germany
Site Ref # / Investigator 1946
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Heerlen, Netherlands
Site Ref # / Investigator 1905
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Columbia, South Carolina, United States
Site Ref # / Investigator 1919
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Amsterdam, Netherlands
Site Ref # / Investigator 1769
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Germantown, Tennessee, United States
Site Ref # / Investigator 1935
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Box Hill, Victoria, Australia
Site Ref # / Investigator 1938
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Camperdown, New South Wales, Australia
Site Ref # / Investigator 426
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Edmonton, Alberta, Canada
Site Ref # / Investigator 1873
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Halifax, Nova Scotia, Canada
Site Ref # / Investigator 1849
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West Bend, Wisconsin, United States
Site Ref # / Investigator 1941
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Bonheiden, Belgium
Site Ref # / Investigator 1916
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Szekszard, Hungary
Site Ref # / Investigator 1876
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Hamilton, Ontario, Canada
Site Ref # / Investigator 1947
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Warsaw, Poland
Site Ref # / Investigator 1913
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Paris, France
Site Ref # / Investigator 1844
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Johannesburg, GT, South Africa
Site Ref # / Investigator 2524
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Regensburg, Germany
Site Ref # / Investigator 1945
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Rome, Italy
Site Ref # / Investigator 1964
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Amiens, France
Site Ref # / Investigator 1866
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Montreal, Quebec, Canada
Site Ref # / Investigator 1942
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Kiel, Germany
Site Ref # / Investigator 1948
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Szczecin, 71-252, Poland
Site Ref # / Investigator 1846
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Durban, NL, South Africa
Site Ref # / Investigator 341
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Madrid, Spain
Site Ref # / Investigator 1949
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Gothenburg, Sweden
Site Ref # / Investigator 1778
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Stockholm, Sweden
Site Ref # / Investigator 1951
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Edinburgh, United Kingdom
Site Ref # / Investigator 1855
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Charlotte, North Carolina, United States
Site Ref # / Investigator 1882
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Charlote, North Carolina, United States
Site Ref # / Investigator 1899
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Round Rock, Texas, United States
Site Ref # / Investigator 1894
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Huntsville, Alabama, United States
Site Ref # / Investigator 1860
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Englewood, Colorado, United States
Site Ref # / Investigator 1891
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San Diego, California, United States
Site Ref # / Investigator 1787
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La Jolla, California, United States
Site Ref # / Investigator 1902
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Roseville, California, United States
Site Ref # / Investigator 1904
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Wheat Ridge, Colorado, United States
Site Ref # / Investigator 6178
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Lone Tree, Colorado, United States
Site Ref # / Investigator 1883
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Gainesville, Florida, United States
Site Ref # / Investigator 1884
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Ormond Beach, Florida, United States
Site Ref # / Investigator 1909
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Hollywood, Florida, United States
Site Ref # / Investigator 1912
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Atlanta, Georgia, United States
Site Ref # / Investigator 1885
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Anderson, Indiana, United States
Site Ref # / Investigator 1823
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Peoria, Illinois, United States
Site Ref # / Investigator 1890
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Indianapolis, Indiana, United States
Site Ref # / Investigator 1892
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Lexington, Kentucky, United States
Site Ref # / Investigator 1887
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Silver Spring, Maryland, United States
Site Ref # / Investigator 1782
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Lutherville, Maryland, United States
Site Ref # / Investigator 1853
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Mexico, Missouri, United States
Site Ref # / Investigator 2602
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Worcester, Massachusetts, United States
Site Ref # / Investigator 1773
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Plymouth, Minnesota, United States
Site Ref # / Investigator 1888
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St. Louis, Missouri, United States
Site Ref # / Investigator 1848
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Lake Success, New York, United States
Site Ref # / Investigator 1862
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St. Louis, Missouri, United States
Site Ref # / Investigator 1825
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Great Neck, New York, United States
Site Ref # / Investigator 1841
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New York, New York, United States
Site Ref # / Investigator 1911
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Raleigh, North Carolina, United States
Site Ref # / Investigator 1861
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Wilmington, North Carolina, United States
Site Ref # / Investigator 1784
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Beachwood, Ohio, United States
Site Ref # / Investigator 1833
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Cincinatti, Ohio, United States
Site Ref # / Investigator 1896
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Beaver Creek, Ohio, United States
Site Ref # / Investigator 6180
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Charlottesville, Virginia, United States
Site Ref # / Investigator 1783
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Danville, Virginia, United States
Site Ref # / Investigator 1897
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Norfolk, Virginia, United States
Site Ref # / Investigator 1850
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Spokane, Washington, United States
Site Ref # / Investigator 1831
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Milwaukee, Wisconsin, United States
Site Ref # / Investigator 1940
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Bedford Park, South Australia, Australia
Site Ref # / Investigator 1868
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Calgary, Alberta, Canada
Site Ref # / Investigator 1870
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Victoria, British Columbia, Canada
Site Ref # / Investigator 1872
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Vancouver, British Columbia, Canada
Site Ref # / Investigator 1874
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Winnipeg, Manitoba, Canada
Site Ref # / Investigator 1875
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London, Ontario, Canada
Site Ref # / Investigator 1865
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Toronto, Ontario, Canada
Site Ref # / Investigator 1771
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Rotherham, United Kingdom
Site Ref # / Investigator 1880
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Kansas City, Missouri, United States