Trials / Terminated
TerminatedNCT03017014
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 62 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Main secondary objectives are to describe growth and pubertal development and to describe long-term safety. The participants will be followed-up up to 10 years.
Conditions
Timeline
- Start date
- 2017-09-26
- Primary completion
- 2019-10-14
- Completion
- 2019-10-14
- First posted
- 2017-01-11
- Last updated
- 2020-10-08
Locations
24 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03017014. Inclusion in this directory is not an endorsement.