Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)
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
2 other identifiers
interventional
1,000
1 country
97
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2006
Shorter than P25 for phase_3
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 29, 2007
November 1, 2007
June 19, 2006
November 28, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
AEs, laboratory data, physical examinations and vital signs
Secondary Outcomes (1)
Efficacy variables will be assessed from Outcomes Questionnaires
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Previous treatment with adalimumab.
- Patient considered by the investigator, for any reason, to be an unsuitable candidate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (97)
Unknown Facility
Birmingham, Alabama, 35209, United States
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Jonesboro, Arkansas, 72401, United States
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Little Rock, Arkansas, 72205, United States
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Roseville, California, 95661, United States
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San Francisco, California, 94115, United States
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Englewood, Colorado, 80113, United States
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Wheat Ridge, Colorado, 80033, United States
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Bridgeport, Connecticut, 06606, United States
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Hamden, Connecticut, 06518, United States
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Clearwater, Florida, 33765, United States
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Gainesville, Florida, 32607, United States
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Gainesville, Florida, 32610, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32224, United States
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Jacksonville, Florida, 32256, United States
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Miami, Florida, 33173, United States
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North Miami Beach, Florida, 33162, United States
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Winter Park, Florida, 32789, United States
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Atlanta, Georgia, 30308, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30342, United States
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Conyers, Georgia, 30012, United States
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Marietta, Georgia, 30060, United States
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Savannah, Georgia, 31405, United States
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Arlington Heights, Illinois, 60005, United States
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Moline, Illinois, 61265, United States
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Rockford, Illinois, 61107, United States
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Columbus, Indiana, 47201, United States
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Indianapolis, Indiana, 46202-5250, United States
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Indianapolis, Indiana, 46237, United States
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Clive, Iowa, 50325, United States
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Davenport, Iowa, 52807, United States
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Overland Park, Kansas, 66212, United States
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Topeka, Kansas, 66606, United States
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Lexington, Kentucky, 40536, United States
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Annapolis, Maryland, 21401, United States
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Chevy Chase, Maryland, 20815, United States
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Lutherville, Maryland, 21093, United States
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Silver Spring, Maryland, 20901, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02118, United States
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Burlington, Massachusetts, 01805, United States
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Troy, Michigan, 48098, United States
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Plymouth, Minnesota, 55446, United States
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Picayune, Mississippi, 39466, United States
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Kansas City, Missouri, 64131, United States
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Mexico, Missouri, 65265-3726, United States
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St Louis, Missouri, 63128, United States
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Lebanon, New Hampshire, 03756, United States
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Egg Harbor, New Jersey, 08234, United States
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Glen Ridge, New Jersey, 07028, United States
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Manalapan, New Jersey, 07726, United States
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Great Neck, New York, 11021, United States
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Lake Success, New York, 11042, United States
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New York, New York, 10021, United States
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New York, New York, 10022, United States
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New York, New York, 10028, United States
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New York, New York, 10128, United States
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Rochester, New York, 14607, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28211, United States
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Jacksonville, North Carolina, 28546, United States
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Rocky Mount, North Carolina, 27804, United States
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Wilmington, North Carolina, 28401, United States
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Wilmington, North Carolina, 28403, United States
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Beachwood, Ohio, 44122, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45220, United States
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Cincinnati, Ohio, 45242, United States
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Cleveland, Ohio, 44195, United States
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Warren, Ohio, 44484, United States
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Tulsa, Oklahoma, 74104, United States
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Tulsa, Oklahoma, 74135, United States
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Portland, Oregon, 97220, United States
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Portland, Oregon, 97225, United States
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Beaver Falls, Pennsylvania, 15010, United States
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Duncansville, Pennsylvania, 16635, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Sayre, Pennsylvania, 18840, United States
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Columbia, South Carolina, 29204, United States
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Chattanooga, Tennessee, 37403, United States
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Chattanooga, Tennessee, 37404, United States
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Germantown, Tennessee, 38138, United States
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Austin, Texas, 78745, United States
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South Ogden, Utah, 84405, United States
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Norfolk, Virginia, 23502, United States
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Bellevue, Washington, 98004, United States
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Seattle, Washington, 98101, United States
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Spokane, Washington, 99204, United States
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Vancouver, Washington, 98664, United States
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Milwaukee, Wisconsin, 53215, United States
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Milwaukee, Wisconsin, 53226, United States
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Milwaukee, Wisconsin, 53233, United States
Unknown Facility
Monroe, Wisconsin, 53566, United States
Related Publications (1)
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.
PMID: 20955442DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Beverly Paperiello
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 20, 2006
Study Start
June 1, 2006
Study Completion
May 1, 2007
Last Updated
November 29, 2007
Record last verified: 2007-11