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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

NCT03017014•AbbVie

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 17 years

Sex

ALL

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.

Locations (24)

Centre Hospitalier Lyon Sud /ID# 152667

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Centre Hospitalier Lyon Sud /ID# 152668

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Hopital Clocheville /ID# 152831

Tours, Centre-Val de Loire, France

CHU de Besancon - Jean Minjoz /ID# 154197

Besançon, Doubs, France

Hopitaux de Brabois Adultes /ID# 152729

Vandœuvre-lès-Nancy, Lorraine, France

CHU Toulouse /ID# 153251

Toulouse, Occitanie, France

CHU Batiment Robert Debre /ID# 152665

Angers, France

CHU Bordeaux-Hopital Pellegrin /ID# 154620

Bordeaux, France

Chu de Bordeaux Hopital /Id# 157926

Bordeaux, France

Centre Hospitalier Universitai /ID# 155465

Caen, France

Key Dates

Start Date

September 26, 2017

Primary Completion Date

October 14, 2019

Completion Date

October 14, 2019

Last Updated

October 8, 2020

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease