EUCTR2013-003032-77-PL
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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Enrollment
- 93
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
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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