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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338650

  Show 97 Study Locations
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 July 23, 2014