Clinical Trials Directory

Trials / Completed

CompletedNCT00573794

Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

A Multicenter, 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 Ulcerative Colitis

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
592 (actual)
Sponsor
AbbVie (prior sponsor, Abbott) · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).

Conditions

Interventions

TypeNameDescription
BIOLOGICALadalimumabadalimumab prefilled syringes administered as subcutaneous injection EW or EOW

Timeline

Start date
2007-11-28
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2007-12-14
Last updated
2021-07-07
Results posted
2017-12-19

Source: ClinicalTrials.gov record NCT00573794. Inclusion in this directory is not an endorsement.