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

October 6, 2020 updated by: AbbVie

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU Batiment Robert Debre /ID# 152665
      • Bordeaux, France, 33076
        • CHU Bordeaux-Hopital Pellegrin /ID# 154620
      • Bordeaux, France, 33076
        • Chu de Bordeaux Hopital /Id# 157926
      • Caen, France, 14033
        • Centre Hospitalier Universitai /ID# 155465
      • Clermont Ferrand, France, 63100
        • CHU Hopital d'Estaing /ID# 152664
      • Lille, France, 59037
        • Hopital Jeanne de Flandre /Id# 155464
      • Marseille, France, 13385
        • Hopital de la Timone /ID# 160133
      • Montivillier, France, 76290
        • Hopital Jacques Monod /ID# 152663
      • Orleans, France, 45067
        • Hopital de la Source /ID# 159947
      • Orleans, France, 45067
        • Hopital de la Source /ID# 165534
      • Paris, France, 75019
        • Robert Debre Hopital, FR /ID# 152666
      • Paris, France, 75571
        • Hopital Armand Trousseau /Id# 152669
      • Paris, France, 75571
        • Hopital Armand Trousseau /Id# 157092
      • Paris, France, 75743
        • Necker Hopital, FR /ID# 152830
      • Pierre Benite, France, 69495
        • Chu Lyon Sud /Id# 152838
      • Rennes, France, 35203
        • CHU de Rennes - Hospital Sud /ID# 152730
      • Rouen, France, 76031
        • Charles Nicolle Hosp chu rouen /ID# 152670
      • Rouen, France, 76031
        • Charles Nicolle Hosp chu rouen /ID# 158688
    • Auvergne-Rhone-Alpes
      • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
        • Centre Hospitalier Lyon Sud /ID# 152667
      • Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France, 69495
        • Centre Hospitalier Lyon Sud /ID# 152668
    • Centre-Val De Loire
      • Tours, Centre-Val De Loire, France, 37044
        • Hopital Clocheville /ID# 152831
    • Doubs
      • Besancon, Doubs, France, 25000
        • CHU de Besancon - Jean Minjoz /ID# 154197
    • Lorraine
      • Vandoeuvre les Nancy, Lorraine, France, 54500
        • Hopitaux de Brabois Adultes /ID# 152729
    • Occitanie
      • Toulouse CEDEX 3, Occitanie, France, 31025
        • CHU Toulouse /ID# 153251

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants are children and adolescents with Crohn's disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Pediatric participants receiving adalimumab
Pediatric participants receiving adalimumab for CD in real-life conditions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to loss of clinical benefit
Time Frame: Up to 12 years

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants with dose escalation (dose and/or frequency of injections)
Time Frame: Up to 12 years
Dosing and/or frequency of injections is monitored to assess dose escalation.
Up to 12 years
Median percent change from baseline in C-reactive protein (CRP)
Time Frame: From Month 0 to 12 years
The median percent change from baseline in CRP is assessed at each time point.
From Month 0 to 12 years
Median percent change from baseline in calprotectin
Time Frame: From Month 0 to 12 years
The median percent change from baseline in calprotectin us assessed at each time point.
From Month 0 to 12 years
Change from baseline in weighted Pediatric Crohn's Disease Activity Index (PCDAI)
Time Frame: From Month 0 to 12 years
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
Change in wPCDAI >= 37.5
Time Frame: From Month 0 to 12 years
A change in wPCDAI >= 37.5 indicates improvement.
From Month 0 to 12 years
Incidence rate of CD-related hospitalizations
Time Frame: Up to 12 years
Hospitalization will be determined from the health care utilization information.
Up to 12 years
Rate of clinical remission
Time Frame: Up to 12 years
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
Proportion of participants achieving mucosal healing at each time point
Time Frame: Up to 12 years
Mucosal healing is assessed using SES-CD score (0 or 1).
Up to 12 years
Proportion of participants with steroid-free clinical remission at each time point
Time Frame: Up to 12 years
The proportion of participants with steroid-free clinical remission is assessed at each time point.
Up to 12 years
Change in weight z-score
Time Frame: From Month 0 to 12 years
Growth is assessed by monitoring changes in weight z-score.
From Month 0 to 12 years
Median percent change from baseline in high sensitivity C-reactive protein (hs-CRP)
Time Frame: From Month 0 to 12 years
The median percent change from baseline in hs-CRP is assessed at each time point.
From Month 0 to 12 years
Assessing Mucosal healing
Time Frame: Up to 12 years
Mucosal healing is assessed using Simple Endoscopic Score for Cronh's Disease (SES-CD) score (0 or 1).
Up to 12 years
Rate of steroid-free remission
Time Frame: Up to 12 years
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
Proportion of participants with fistula remission (in participants with fistulizing CD at entry)
Time Frame: Up to 12 years
Fistula remission is defined as closure for at least 2 consecutive visits of all fistulae that were draining at baseline
Up to 12 years
Change in Tanner's staging
Time Frame: From Month 0 to 12 years
Tanner's staging is used to assess growth and pubertal development.
From Month 0 to 12 years
Proportion of participants with immunomodulator-free clinical remission at each time point
Time Frame: Up to 12 years
The proportion of participants with immunomodulator-free clinical remission is assessed at each time point.
Up to 12 years
Incidence rate of infectious events
Time Frame: Up to 12 years
The incidence rate of serious and non-serious opportunistic infections is assessed.
Up to 12 years
Incidence rate of all-cause hospitalizations
Time Frame: Up to 12 years
Hospitalization will be determined from the health care utilization information.
Up to 12 years
Proportion of participants with steroid tapering at each time point (steroids daily dosing lower than at baseline)
Time Frame: Up to 12 years
The proportion of participants with steroid tapering i.e., steroids daily dosing lower than at baseline (week 0) is assessed.
Up to 12 years
Change in height z-score
Time Frame: From Month 0 to 12 years
Growth is assessed by monitoring changes in height z-score
From Month 0 to 12 years
Proportion of participants with CD-related surgery
Time Frame: Up to 12 years
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
Incidence rate of CD- or drug-related hospitalizations
Time Frame: Up to 12 years
Hospitalization will be determined from the health care utilization information.
Up to 12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P15-759

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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