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Clinical Trials/EUCTR2013-003032-77-AT
EUCTR2013-003032-77-AT
Active, not recruiting
Phase 1

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis.

Abbvie Deutschland GmbH & Co. KG0 sites101 target enrollmentJanuary 8, 2014
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Conditionslcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsHumira 40 mg/0.8 ml solution for injection for paediatric use

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
lcerative colitis
Sponsor
Abbvie Deutschland GmbH & Co. KG
Enrollment
101
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 8, 2014
End Date
February 7, 2020
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •? Subjects from the ages of 4 to 17 prior to baseline dosing.
  • •? Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy
  • •? Active ulcerative colitis with a Mayo Score of 6 – 12 points and endoscopy subscore of 2 – 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 93
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •? Subject with Crohn's disease (CD) or indeterminate colitis (IC).
  • •? Current diagnosis of fulminant colitis and/or toxic megacolon.
  • •? Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
  • •? Chronic recurring infections or active TB

Outcomes

Primary Outcomes

Not specified

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