NCT02065557

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT02065557

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Summary

The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

Eligibility

Inclusion Criteria:

* 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.

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 tuberculosis (TB).

Disease(s) and\or Condition(s)

Ulcerative Colitis

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: Adalimumab
- Description: Subcutaneous (SC) injection
- Arm Group Labels: Adalimumab Induction High Dose, Adalimumab Induction High Dose - Open Label, Adalimumab Induction Standard Dose, Adalimumab Maintenance High Dose, Adalimumab Maintenance Standard Dose, Maintenance Placebo
- Type: BIOLOGICAL
- Name: Placebo
- Description: Subcutaneous (SC) injection
- Arm Group Labels: Adalimumab Induction Standard Dose, Maintenance Placebo

Sponsor

AbbVie