Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)

NCT ID: NCT00338650

Last Updated: 2007-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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adalimumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Beverly Paperiello

Role: STUDY_DIRECTOR

Abbott

Locations

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Birmingham, Alabama, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Roseville, California, United States

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San Francisco, California, United States

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Englewood, Colorado, United States

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Wheat Ridge, Colorado, United States

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Bridgeport, Connecticut, United States

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Hamden, Connecticut, United States

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Clearwater, Florida, United States

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Gainesville, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Conyers, Georgia, United States

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Marietta, Georgia, United States

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Savannah, Georgia, United States

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Arlington Heights, Illinois, United States

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Moline, Illinois, United States

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Rockford, Illinois, United States

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Columbus, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Clive, Iowa, United States

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Davenport, Iowa, United States

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Overland Park, Kansas, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Annapolis, Maryland, United States

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Chevy Chase, Maryland, United States

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Lutherville, Maryland, United States

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Silver Spring, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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Troy, Michigan, United States

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Plymouth, Minnesota, United States

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Picayune, Mississippi, United States

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Kansas City, Missouri, United States

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Mexico, Missouri, United States

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St Louis, Missouri, United States

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Lebanon, New Hampshire, United States

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Egg Harbor, New Jersey, United States

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Glen Ridge, New Jersey, United States

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Manalapan, New Jersey, United States

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Great Neck, New York, United States

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Lake Success, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Jacksonville, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Wilmington, North Carolina, United States

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Wilmington, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Warren, Ohio, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Beaver Falls, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Columbia, South Carolina, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Austin, Texas, United States

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South Ogden, Utah, United States

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Norfolk, Virginia, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Vancouver, Washington, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Monroe, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20955442 (View on PubMed)

Other Identifiers

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CHOICE

Identifier Type: -

Identifier Source: secondary_id

M06-808

Identifier Type: -

Identifier Source: org_study_id