Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 11/24/2017 |
| Start Date: | November 2007 |
| End Date: | December 2016 |
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
To assess the long-term safety and maintenance of response of adalimumab in subjects with
ulcerative colitis.
ulcerative colitis.
Inclusion Criteria:
- Subject must have successfully enrolled and completed either the M06-826 study or the
M06-827 study
- Subject is judged to be in generally good health as determined by the principal
investigator
Exclusion Criteria:
- Subject has not responded to weekly adalimumab therapy in M06-826 or M06-827
- Subject considered by the investigator, for any reason, to be an unsuitable candidate
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
We found this trial at
43
sites
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