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

Abbott0 sites1,000 target enrollmentJune 2006

ConditionsCrohn's Disease

Drugsadalimumab

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: Abbott
Enrollment: 1000
Primary Endpoint: AEs, laboratory data, physical examinations and vital signs
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

May 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott

Eligibility 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.