NCT00195715

Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 777 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	Adalimumab 40 mg by subcutaneous injection every other week or every week

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-03-01
• Completion: 2008-12-01
• First posted: 2005-09-20
• Last updated: 2011-07-12
• Results posted: 2010-01-07

Locations

111 sites across 15 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden, United Kingdom