Clinical trial NCT00338650: Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)
Official title: A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 1000
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: The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with moderate to severe Crohn's Disease.
* Failed prior infliximab therapy.
* Patient is judged to be in generally good health as determined by the principal investigator.

Exclusion Criteria:

* Previous treatment with adalimumab.
* Patient considered by the investigator, for any reason, to be an unsuitable candidate

Primary outcomes:
measure: AEs, laboratory data, physical examinations and vital signs
Secondary outcomes:
measure: Efficacy variables will be assessed from Outcomes Questionnaires
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Roseville
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Hamden
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Moline
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Columbus
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Clive
country: United States
state: Iowa
city: Davenport
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Annapolis
country: United States
state: Maryland
city: Chevy Chase
country: United States
state: Maryland
city: Lutherville
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: Plymouth
country: United States
state: Minnesota
city: Picayune
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Mexico
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Egg Harbor Township
country: United States
state: New Jersey
city: Glen Ridge
country: United States
state: New Jersey
city: Manalapan
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Jacksonville
country: United States
state: North Carolina
city: Rocky Mount
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Warren
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Beaver Falls
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sayre
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: South Ogden
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Monroe
country: United States
state: Wisconsin
Study officials:
affiliation: Abbott
name: Beverly Paperiello
role: STUDY_DIRECTOR
References:
citation: Lichtiger S, Binion DG, Wolf DC, Present DH, Bensimon AG, Wu E, Yu AP, Cardoso AT, Chao J, Mulani PM, Lomax KG, Kent JD. The CHOICE trial: adalimumab demonstrates safety, fistula healing, improved quality of life and increased work productivity in patients with Crohn's disease who failed prior infliximab therapy. Aliment Pharmacol Ther. 2010 Nov;32(10):1228-39. doi: 10.1111/j.1365-2036.2010.04466.x. Epub 2010 Sep 28.