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.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00338650

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 III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune Infliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Show 97 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Beverly Paperiello

Abbott

More Information

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

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Infliximab
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Adalimumab
Gastroenteritis
Intestinal Diseases
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009