The trial is taking place at:
C

Centrum Zdrowia MDM | Gastroenterology

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

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AbbVie

Status and phase

Active, not recruiting
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)

59 participants in 1 patient group

Subjects receiving Adalimumab
Experimental group
Description:
Subjects receiving Adalimumab up to 288 weeks
Treatment:
Biological: Adalimumab

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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