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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 (LEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017014
Recruitment Status : Terminated (Low enrollment)
First Posted : January 11, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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.

Condition or disease
Crohn's Disease

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA
Actual Study Start Date : September 26, 2017
Actual Primary Completion Date : October 14, 2019
Actual Study Completion Date : October 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in wPCDAI >= 37.5 [ Time Frame: From Month 0 to 12 years ]
    A change in wPCDAI >= 37.5 indicates improvement.

  6. Incidence rate of CD-related hospitalizations [ Time Frame: Up to 12 years ]
    Hospitalization will be determined from the health care utilization information.

  7. 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

  8. 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).

  9. 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.

  10. Change in weight z-score [ Time Frame: From Month 0 to 12 years ]
    Growth is assessed by monitoring changes in weight z-score.

  11. 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.

  12. 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).

  13. 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.

  14. 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

  15. Change in Tanner's staging [ Time Frame: From Month 0 to 12 years ]
    Tanner's staging is used to assess growth and pubertal development.

  16. 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.

  17. Incidence rate of infectious events [ Time Frame: Up to 12 years ]
    The incidence rate of serious and non-serious opportunistic infections is assessed.

  18. Incidence rate of all-cause hospitalizations [ Time Frame: Up to 12 years ]
    Hospitalization will be determined from the health care utilization information.

  19. 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.

  20. Change in height z-score [ Time Frame: From Month 0 to 12 years ]
    Growth is assessed by monitoring changes in height z-score

  21. 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.

  22. Incidence rate of CD- or drug-related hospitalizations [ Time Frame: Up to 12 years ]
    Hospitalization will be determined from the health care utilization information.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are children and adolescents with Crohn's disease
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017014


Locations
Show Show 24 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03017014    
Other Study ID Numbers: P15-759
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
Crohn's Disease
Adalimumab
Humira®
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases