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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.
Information provided by:
Abbott Identifier:
First received: June 19, 2006
Last updated: November 28, 2007
Last verified: November 2007
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
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:

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00338650

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00338650     History of Changes
Other Study ID Numbers: M06-808
Study First Received: June 19, 2006
Last Updated: November 28, 2007

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents processed this record on May 25, 2017