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

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

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

Primary outcomes

AEs, laboratory data, physical examinations and vital signs

Secondary outcomes

Efficacy variables will be assessed from Outcomes Questionnaires

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Study completion: 2007
First posted: Jun 20, 2006
Registry last updated: Nov 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed