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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00338650
First received: June 19, 2006
Last updated: November 28, 2007
Last verified: November 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Crohn's Disease
 Drug: adalimumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • AEs, laboratory data, physical examinations and vital signs

Secondary Outcome Measures:
  • Efficacy variables will be assessed from Outcomes Questionnaires

Estimated Enrollment: 1000
Study Start Date: June 2006
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338650

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35209
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Roseville, California, United States, 95661
San Francisco, California, United States, 94115
United States, Colorado
Englewood, Colorado, United States, 80113
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
Hamden, Connecticut, United States, 06518
United States, Florida
Clearwater, Florida, United States, 33765
Gainesville, Florida, United States, 32610
Gainesville, Florida, United States, 32607
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32224
Jacksonville, Florida, United States, 32256
Miami, Florida, United States, 33173
North Miami Beach, Florida, United States, 33162
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta, Georgia, United States, 30342
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30308
Conyers, Georgia, United States, 30012
Marietta, Georgia, United States, 30060
Savannah, Georgia, United States, 31405
United States, Illinois
Arlington Heights, Illinois, United States, 60005
Moline, Illinois, United States, 61265
Rockford, Illinois, United States, 61107
United States, Indiana
Columbus, Indiana, United States, 47201
Indianapolis, Indiana, United States, 46237
Indianapolis, Indiana, United States, 46202-5250
United States, Iowa
Clive, Iowa, United States, 50325
Davenport, Iowa, United States, 52807
United States, Kansas
Overland Park, Kansas, United States, 66212
Topeka, Kansas, United States, 66606
United States, Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Annapolis, Maryland, United States, 21401
Chevy Chase, Maryland, United States, 20815
Lutherville, Maryland, United States, 21093
Silver Spring, Maryland, United States, 20901
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02118
Burlington, Massachusetts, United States, 01805
United States, Michigan
Troy, Michigan, United States, 48098
United States, Minnesota
Plymouth, Minnesota, United States, 55446
United States, Mississippi
Picayune, Mississippi, United States, 39466
United States, Missouri
Kansas City, Missouri, United States, 64131
Mexico, Missouri, United States, 65265-3726
St. Louis, Missouri, United States, 63128
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Egg Harbor Township, New Jersey, United States, 08234
Glen Ridge, New Jersey, United States, 07028
Manalapan, New Jersey, United States, 07726
United States, New York
Great Neck, New York, United States, 11021
Lake Success, New York, United States, 11042
New York, New York, United States, 10028
New York, New York, United States, 10128
New York, New York, United States, 10022
New York, New York, United States, 10021
Rochester, New York, United States, 14607
United States, North Carolina
Charlotte, North Carolina, United States, 28211
Charlotte, North Carolina, United States, 28207
Jacksonville, North Carolina, United States, 28546
Rocky Mount, North Carolina, United States, 27804
Wilmington, North Carolina, United States, 28401
Wilmington, North Carolina, United States, 28403
United States, Ohio
Beachwood, Ohio, United States, 44122
Cincinnati, Ohio, United States, 45220
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45242
Cleveland, Ohio, United States, 44195
Warren, Ohio, United States, 44484
United States, Oklahoma
Tulsa, Oklahoma, United States, 74135
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Portland, Oregon, United States, 97220
Portland, Oregon, United States, 97225
United States, Pennsylvania
Beaver Falls, Pennsylvania, United States, 15010
Duncansville, Pennsylvania, United States, 16635
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15224
Pittsburgh, Pennsylvania, United States, 15232
Pittsburgh, Pennsylvania, United States, 15243
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Columbia, South Carolina, United States, 29204
United States, Tennessee
Chattanooga, Tennessee, United States, 37403
Chattanooga, Tennessee, United States, 37404
Germantown, Tennessee, United States, 38138
United States, Texas
Austin, Texas, United States, 78745
United States, Utah
South Ogden, Utah, United States, 84405
United States, Virginia
Norfolk, Virginia, United States, 23502
United States, Washington
Bellevue, Washington, United States, 98004
Seattle, Washington, United States, 98101
Spokane, Washington, United States, 99204
Vancouver, Washington, United States, 98664
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53233
Milwaukee, Wisconsin, United States, 53215
Milwaukee, Wisconsin, United States, 53226
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00338650     History of Changes
Other Study ID Numbers: M06-808, CHOICE
Study First Received: June 19, 2006
Last Updated: November 28, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Infliximab
Adalimumab
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013