Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

AbbVie

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Biological: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02632175

M10-870

2015-001346-29 (EudraCT Number)

Details and patient eligibility

About

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

Enrollment: 59 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- Subject must have successfully enrolled and completed M11-290 study

Exclusion criteria

- Subject considered by the investigator, for any reason, to be an unsuitable candidate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Subjects receiving Adalimumab

Experimental group

Description:

Subjects receiving Adalimumab up to 288 weeks

Treatment:

Biological: Adalimumab