Trials / Completed
CompletedNCT01083680
Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
Post-marketing Observational Study to Evaluate the Safety and Efficacy of HUMIRA® (Adalimumab SC) for the Treatment of Moderate to Severe Crohn's Disease in Daily Clinical Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,107 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.
Detailed description
This study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with CD who resided in Germany. Visits were scheduled every 3 months for the first year and every 6 months thereafter. Participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.
Conditions
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2010-03-10
- Last updated
- 2017-04-04
- Results posted
- 2017-04-04
Source: ClinicalTrials.gov record NCT01083680. Inclusion in this directory is not an endorsement.