A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/21/2016 |
Start Date: | September 2007 |
End Date: | December 2015 |
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
The primary objective of this Registry study is to evaluate the long-term safety and
effectiveness of adalimumab in CD subjects who are treated as recommended in the product
label.
effectiveness of adalimumab in CD subjects who are treated as recommended in the product
label.
Inclusion Criteria: - Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have
never been treated with adalimumab) or who are participants in Abbvie sponsored
investigational CD trials, are currently receiving adalimumab and for whom the treating
physician has made the decision to continue with adalimumab therapy beyond the duration of
the investigational trial.
- Subjects who were participants in AbbVie sponsored investigational Crohn's disease
trials, who have not had dose interruptions since the last dose of study drug, where
the Investigator can provide source documentation of dosing information.
- Subjects who are currently receiving adalimumab, as per the local approved label, who
have not had dose interruptions since the induction dose of adalimumab where the
Investigator can provide source documentation of dosing information.
- Subjects willing to consent to data being collected and provided to AbbVie.
- Subjects capable of and willing to give written informed consent and to comply with
the requirements of the Registry study protocol.
Exclusion Criteria: - Subjects should not be enrolled if they cannot be treated in
accordance with the local product label.
We found this trial at
105
sites
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