A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions (LEA)

AbbVie

Status: Terminated

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03017014

P15-759

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With confirmed diagnosis of Crohn's disease
• Adalimumab-naïve patient (a patient having received an anti-TNF other than adalimumab may enter the study)
• Starting a treatment with adalimumab
• Guardian capable of and willing to grant authorization for use/disclosure of data collected and patient able to comply with the requirements of the study protocol.

Exclusion criteria

• Participants with a history of treatment with adalimumab
• Participants enrolled in a concomitant interventional clinical trial.

Trial design

62 participants in 1 patient group

Pediatric participants receiving adalimumab

Description:

Pediatric participants receiving adalimumab for CD in real-life conditions.