Clinical trial NCT00195715: Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 777
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Achieving Clinical Remission
timeFrame: Week 156
Secondary outcomes:
measure: Percentage of Subjects Achieving Clinical Remission
timeFrame: Week 48
measure: Percentage of Subjects Achieving Clinical Remission
timeFrame: Week 108
measure: Percentage of Subjects Achieving Clinical Remission
timeFrame: Week 204
measure: Percentage of Subjects Achieving Clinical Response 100 (CR-100)
timeFrame: Week 156
measure: Percentage of Subjects Achieving Clinical Response 70 (CR-70)
timeFrame: Week 156
measure: Percentage of Subjects Achieving Steroid-free Clinical Remission
timeFrame: Week 156
measure: Percentage of Subjects Achieving Steroid-free CR-100
timeFrame: Week 156
measure: Percentage of Subjects With Fistula Remission
timeFrame: Week 156
measure: Percentage of Subjects With Infection
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Serious Infection
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Malignancy
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Lymphoma
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Nonmelanoma Skin Cancer
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Injection Site Reaction-related Adverse Event
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Congestive Heart Failure
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Demyelinating Disease
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Hepatic-related Adverse Event
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Allergic Reaction-related Adverse Event
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Lupus-like Syndrome
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Hematologic-related Adverse Event
timeFrame: Up to 262 weeks of adalimumab treatment
measure: Percentage of Subjects With Fatal Adverse Event
timeFrame: Up to 262 weeks of adalimumab treatment
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site Ref # / Investigator 1894
state: Alabama
city: Jacksonville
country: United States
facility: Site Ref # / Investigator 1895
state: Alabama
city: La Jolla
country: United States
facility: Site Ref # / Investigator 1787
state: California
city: Roseville
country: United States
facility: Site Ref # / Investigator 1902
state: California
city: San Diego
country: United States
facility: Site Ref # / Investigator 1824
state: California
city: San Diego
country: United States
facility: Site Ref # / Investigator 1891
state: California
city: Englewood
country: United States
facility: Site Ref # / Investigator 1860
state: Colorado
city: Lone Tree
country: United States
facility: Site Ref # / Investigator 6178
state: Colorado
city: Wheat Ridge
country: United States
facility: Site Ref # / Investigator 1904
state: Colorado
city: Bridgeport
country: United States
facility: Site Ref # / Investigator 1858
state: Connecticut
city: Clearwater
country: United States
facility: Site Ref # / Investigator 1827
state: Florida
city: Gainesville
country: United States
facility: Site Ref # / Investigator 1883
state: Florida
city: Hollywood
country: United States
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state: Florida
city: Ormond Beach
country: United States
facility: Site Ref # / Investigator 1884
state: Florida
city: Winter Park
country: United States
facility: Site Ref # / Investigator 1786
state: Florida
city: Atlanta
country: United States
facility: Site Ref # / Investigator 1912
state: Georgia
city: Arlington Heights
country: United States
facility: Site Ref # / Investigator 1878
state: Illinois
city: Chicago
country: United States
facility: Site Ref # / Investigator 2534
state: Illinois
city: Peoria
country: United States
facility: Site Ref # / Investigator 1823
state: Illinois
city: Anderson
country: United States
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state: Indiana
city: Indianapolis
country: United States
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state: Indiana
city: Indianapolis
country: United States
facility: Site Ref # / Investigator 1890
state: Indiana
city: Lexington
country: United States
facility: Site Ref # / Investigator 1892
state: Kentucky
city: Metairie
country: United States
facility: Site Ref # / Investigator 1906
state: Louisiana
city: Annapolis
country: United States
facility: Site Ref # / Investigator 1881
state: Maryland
city: Chevy Chase
country: United States
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state: Maryland
city: Lutherville
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state: Maryland
city: Silver Spring
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state: Maryland
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state: Minnesota
city: Rochester
country: United States
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state: Minnesota
city: Jackson
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state: Mississippi
city: Kansas City
country: United States
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state: Missouri
city: Mexico
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state: Missouri
city: St. Louis
country: United States
facility: Site Ref # / Investigator 1888
state: Missouri
city: St. Louis
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state: Missouri
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state: New Jersey
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city: Lake Success
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state: New York
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state: North Carolina
city: Charlote
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Wilmington
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facility: Site Ref # / Investigator 1861
state: North Carolina
city: Beachwood
country: United States
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state: Ohio
city: Beaver Creek
country: United States
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state: Ohio
city: Cincinatti
country: United States
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state: Ohio
city: Cleveland
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facility: Site Ref # / Investigator 1826
state: Ohio
city: Portland
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state: Oregon
city: Pittsburgh
country: United States
facility: Site Ref # / Investigator 1886
state: Pennsylvania
city: Columbia
country: United States
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state: South Carolina
city: Germantown
country: United States
facility: Site Ref # / Investigator 1769
state: Tennessee
city: Nashville
country: United States
facility: Site Ref # / Investigator 1907
state: Tennessee
city: Nashville
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facility: Site Ref # / Investigator 1963
state: Tennessee
city: Round Rock
country: United States
facility: Site Ref # / Investigator 1899
state: Texas
city: Salt Lake City
country: United States
facility: Site Ref # / Investigator 1903
state: Utah
city: Charlottesville
country: United States
facility: Site Ref # / Investigator 6180
state: Virginia
city: Danville
country: United States
facility: Site Ref # / Investigator 1783
state: Virginia
city: Norfolk
country: United States
facility: Site Ref # / Investigator 1897
state: Virginia
city: Spokane
country: United States
facility: Site Ref # / Investigator 1850
state: Washington
city: Milwaukee
country: United States
facility: Site Ref # / Investigator 1831
state: Wisconsin
city: West Bend
country: United States
facility: Site Ref # / Investigator 1849
state: Wisconsin
city: Camperdown
country: Australia
facility: Site Ref # / Investigator 1938
state: New South Wales
city: Bedford Park
country: Australia
facility: Site Ref # / Investigator 1940
state: South Australia
city: Box Hill
country: Australia
facility: Site Ref # / Investigator 1935
state: Victoria
city: Parkville
country: Australia
facility: Site Ref # / Investigator 1937
state: Victoria
city: Bonheiden
country: Belgium
facility: Site Ref # / Investigator 1941
city: Brussels
country: Belgium
facility: Site Ref # / Investigator 5189
city: Leuven
country: Belgium
facility: Site Ref # / Investigator 2535
city: Calgary
country: Canada
facility: Site Ref # / Investigator 1868
state: Alberta
city: Edmonton
country: Canada
facility: Site Ref # / Investigator 1924
state: Alberta
city: Edmonton
country: Canada
facility: Site Ref # / Investigator 426
state: Alberta
city: Vancouver
country: Canada
facility: Site Ref # / Investigator 1914
state: British Columbia
city: Vancouver
country: Canada
facility: Site Ref # / Investigator 1872
state: British Columbia
city: Victoria
country: Canada
facility: Site Ref # / Investigator 1870
state: British Columbia
city: Winnipeg
country: Canada
facility: Site Ref # / Investigator 1874
state: Manitoba
city: Halifax
country: Canada
facility: Site Ref # / Investigator 1873
state: Nova Scotia
city: Hamilton
country: Canada
facility: Site Ref # / Investigator 1876
state: Ontario
city: London
country: Canada
facility: Site Ref # / Investigator 1875
state: Ontario
city: Toronto
country: Canada
facility: Site Ref # / Investigator 1772
state: Ontario
city: Toronto
country: Canada
facility: Site Ref # / Investigator 1865
state: Ontario
city: Montreal
country: Canada
facility: Site Ref # / Investigator 2459
state: Quebec
city: Montreal
country: Canada
facility: Site Ref # / Investigator 1866
state: Quebec
city: Quebec City
country: Canada
facility: Site Ref # / Investigator 1863
state: Quebec
city: Arhus C
country: Denmark
facility: Site Ref # / Investigator 1952
city: Odense C
country: Denmark
facility: Site Ref # / Investigator 1922
city: Amiens
country: France
facility: Site Ref # / Investigator 1964
city: Lillie Cedex
country: France
facility: Site Ref # / Investigator 2458
city: Paris
country: France
facility: Site Ref # / Investigator 1913
city: Kiel
country: Germany
facility: Site Ref # / Investigator 1942
city: Regensburg
country: Germany
facility: Site Ref # / Investigator 2524
city: Stuttgart
country: Germany
facility: Site Ref # / Investigator 1943
city: Budapest
country: Hungary
facility: Site Ref # / Investigator 1944
city: Szekszard
country: Hungary
facility: Site Ref # / Investigator 1916
city: Bologna
country: Italy
facility: Site Ref # / Investigator 342
city: Rome
country: Italy
facility: Site Ref # / Investigator 1945
city: Turin
country: Italy
facility: Site Ref # / Investigator 1779
city: Amsterdam
country: Netherlands
facility: Site Ref # / Investigator 1919
city: Heerlen
country: Netherlands
facility: Site Ref # / Investigator 1946
city: Szczecin
country: Poland
facility: Site Ref # / Investigator 1948
state: 71-252
city: Warsaw
country: Poland
facility: Site Ref # / Investigator 1947
city: Johannesburg
country: South Africa
facility: Site Ref # / Investigator 1844
state: GT
city: Durban
country: South Africa
facility: Site Ref # / Investigator 1846
state: NL
city: Cape Town
country: South Africa
facility: Site Ref # / Investigator 1763
state: WC
city: Madrid
country: Spain
facility: Site Ref # / Investigator 341
city: Puerto de Sagunto
country: Spain
facility: Site Ref # / Investigator 2457
city: Gothenburg
country: Sweden
facility: Site Ref # / Investigator 1949
city: Stockholm
country: Sweden
facility: Site Ref # / Investigator 1778
city: Edinburgh
country: United Kingdom
facility: Site Ref # / Investigator 1951
city: Rotherham
country: United Kingdom
facility: Site Ref # / Investigator 1771
Study officials:
affiliation: Abbott
name: Anne Camez, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.