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A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)

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NCT02130362 · readout ≤ 1,564 d

Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.

Phase
Status
Active, not recruiting
Study type
Observational
Enrollment
1,446actual
Sites
148
Countries
Bosnia and Herzegovina, Bulgaria, Canada +19

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2014-08-28actualWhen the study began enrolling
Primary completionNov 2030estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionNov 2030estimatedThe whole study's end, after follow-up
First posted2014-05-05estimatedWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-07-16actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Crohn's Disease

Primary outcomes

what the primary-completion date above is the date OF
Number of treatment-emergent AESI per 100 PYs of infections and malignancies
measured Up to 10 years
Percentage of subjects with SAEs
measured Up to 10 years
Number of treatment-emergent other AESI per 100 PYs
measured Up to 5 years
Percentage of subjects with other AESI
measured Up to 5 years
Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies
measured Up to 10 years
Number of subjects with other AESI
measured Up to 5 years
Number of treatment-emergent SAEs per 100 patient years (PYs)
measured Up to 10 years
Number of subjects with Serious Adverse Events (SAEs)
measured Up to 10 years
Percentage of subjects with AESI of infections, malignancies, and pregnancies
measured Up to 10 years

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