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

Crohn's Disease Clinical Trial

— LEA  

Official title:

Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03017014
• Other study ID #: P15-759
• Status: Terminated
• Start date: September 26, 2017
• Est. completion date: October 14, 2019

Study information

• Verified date: October 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
France	CHU Batiment Robert Debre /ID# 152665	Angers
France	CHU de Besancon - Jean Minjoz /ID# 154197	Besancon	Doubs
France	CHU Bordeaux-Hopital Pellegrin /ID# 154620	Bordeaux
France	Chu de Bordeaux Hopital /Id# 157926	Bordeaux
France	Centre Hospitalier Universitai /ID# 155465	Caen
France	CHU Hopital d'Estaing /ID# 152664	Clermont Ferrand
France	Hopital Jeanne de Flandre /Id# 155464	Lille
France	Hopital de la Timone /ID# 160133	Marseille
France	Hopital Jacques Monod /ID# 152663	Montivillier
France	Hopital de la Source /ID# 159947	Orleans
France	Hopital de la Source /ID# 165534	Orleans
France	Hopital Armand Trousseau /Id# 152669	Paris
France	Hopital Armand Trousseau /Id# 157092	Paris
France	Necker Hopital, FR /ID# 152830	Paris
France	Robert Debre Hopital, FR /ID# 152666	Paris
France	Chu Lyon Sud /Id# 152838	Pierre Benite
France	Centre Hospitalier Lyon Sud /ID# 152667	Pierre Benite CEDEX	Auvergne-Rhone-Alpes
France	Centre Hospitalier Lyon Sud /ID# 152668	Pierre Benite CEDEX	Auvergne-Rhone-Alpes
France	CHU de Rennes - Hospital Sud /ID# 152730	Rennes
France	Charles Nicolle Hosp chu rouen /ID# 152670	Rouen
France	Charles Nicolle Hosp chu rouen /ID# 158688	Rouen
France	CHU Toulouse /ID# 153251	Toulouse CEDEX 3	Occitanie
France	Hopital Clocheville /ID# 152831	Tours	Centre-Val De Loire
France	Hopitaux de Brabois Adultes /ID# 152729	Vandoeuvre les Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to loss of clinical benefit	Loss of clinical benefit will be defined as one of the following: Loss of efficacy leading to adalimumab discontinuation or; Introduction / reinforcement of other immunosuppressants (ratio dose/weight) or; Introduction / reinforcement of corticosteroids (ratio dose/weight; reinforcement of corticosteroids are allowed within the 4 first months after start of adalimumab); Introduction of enteral nutrition; CD-related surgery, discontinuation of adalimumab due to adverse event, death.	Up to 12 years
Secondary	Proportion of participants with dose escalation (dose and/or frequency of injections)	Dosing and/or frequency of injections is monitored to assess dose escalation.	Up to 12 years
Secondary	Median percent change from baseline in C-reactive protein (CRP)	The median percent change from baseline in CRP is assessed at each time point.	From Month 0 to 12 years
Secondary	Median percent change from baseline in calprotectin	The median percent change from baseline in calprotectin us assessed at each time point.	From Month 0 to 12 years
Secondary	Change from baseline in weighted Pediatric Crohn's Disease Activity Index (PCDAI)	The Pediatric Activity Index (PCDAI) has become the standard outcome measure in pediatric Crohn's disease (CD) clinical research. The Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) was developed to add weight to the items in the PCDAI and make it more feasible. In the wPCDAI, growth velocity, abdominal examination, and hematocrit are removed. The wPCDAI score can range from 0-125, with higher signifying severe disease activity.	From Month 0 to 12 years
Secondary	Change in wPCDAI >= 37.5	A change in wPCDAI >= 37.5 indicates improvement.	From Month 0 to 12 years
Secondary	Incidence rate of CD-related hospitalizations	Hospitalization will be determined from the health care utilization information.	Up to 12 years
Secondary	Rate of clinical remission	Clinical remission is weighted PCDAI < 12.5 or Harvey-Bradshaw index (HBI) <5. Rate of clinical remission will be described at each time point	Up to 12 years
Secondary	Proportion of participants achieving mucosal healing at each time point	Mucosal healing is assessed using SES-CD score (0 or 1).	Up to 12 years
Secondary	Proportion of participants with steroid-free clinical remission at each time point	The proportion of participants with steroid-free clinical remission is assessed at each time point.	Up to 12 years
Secondary	Change in weight z-score	Growth is assessed by monitoring changes in weight z-score.	From Month 0 to 12 years
Secondary	Median percent change from baseline in high sensitivity C-reactive protein (hs-CRP)	The median percent change from baseline in hs-CRP is assessed at each time point.	From Month 0 to 12 years
Secondary	Assessing Mucosal healing	Mucosal healing is assessed using Simple Endoscopic Score for Cronh's Disease (SES-CD) score (0 or 1).	Up to 12 years
Secondary	Rate of steroid-free remission	Steroid-free remission is defined as weighted PCDAI < 12.5 or HBI <5 and no daily intake of prednisone (whatever the route). Rate of steroid-free remission will be described at each time point.	Up to 12 years
Secondary	Proportion of participants with fistula remission (in participants with fistulizing CD at entry)	Fistula remission is defined as closure for at least 2 consecutive visits of all fistulae that were draining at baseline	Up to 12 years
Secondary	Change in Tanner's staging	Tanner's staging is used to assess growth and pubertal development.	From Month 0 to 12 years
Secondary	Proportion of participants with immunomodulator-free clinical remission at each time point	The proportion of participants with immunomodulator-free clinical remission is assessed at each time point.	Up to 12 years
Secondary	Incidence rate of infectious events	The incidence rate of serious and non-serious opportunistic infections is assessed.	Up to 12 years
Secondary	Incidence rate of all-cause hospitalizations	Hospitalization will be determined from the health care utilization information.	Up to 12 years
Secondary	Proportion of participants with steroid tapering at each time point (steroids daily dosing lower than at baseline)	The proportion of participants with steroid tapering i.e., steroids daily dosing lower than at baseline (week 0) is assessed.	Up to 12 years
Secondary	Change in height z-score	Growth is assessed by monitoring changes in height z-score	From Month 0 to 12 years
Secondary	Proportion of participants with CD-related surgery	CD-related surgery includes subtotal colectomy with ileorectostomy, colectomy with ileo-anal pouch, Koch pouch, ileostomy, small bowel resection, and etc.	Up to 12 years
Secondary	Incidence rate of CD- or drug-related hospitalizations	Hospitalization will be determined from the health care utilization information.	Up to 12 years

External Links

•   clinical study report synopsis