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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00338650
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : November 29, 2007
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: adalimumab Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2006
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338650


  Show 97 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00338650     History of Changes
Other Study ID Numbers: M06-808
CHOICE
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: November 29, 2007
Last Verified: November 2007

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