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

NCT ID: NCT02632175

Last Updated: 2025-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-26

Study Completion Date

2025-04-08

Brief Summary

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

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects receiving Adalimumab

Subjects receiving Adalimumab up to 288 weeks

Group Type EXPERIMENTAL

Adalimumab

Intervention Type BIOLOGICAL

every other week or weekly subcutaneous injection

Interventions

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Adalimumab

every other week or weekly subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Arnold Palmer Hospital /ID# 147295

Orlando, Florida, United States

Site Status

MNGI Digestive Health, P. A. /ID# 147294

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic - Rochester /ID# 147304

Rochester, Minnesota, United States

Site Status

MultiCare Institute Health System /ID# 169005

Tacoma, Washington, United States

Site Status

Kurume University Hospital /ID# 145710

Kurume-shi, Fukuoka, Japan

Site Status

Juntendo University Hospital /ID# 147315

Bunkyo-ku, Tokyo, Japan

Site Status

National Center for Child Health and Development /ID# 147312

Setagaya-ku, Tokyo, Japan

Site Status

Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Centrum Zdrowia MDM /ID# 147280

Warsaw, Masovian Voivodeship, Poland

Site Status

Gabinet Lekarski Bartosz Korcz /ID# 147281

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status

Instytut Centrum Zdrowia Matki Polki /ID# 169017

Lodz, Łódź Voivodeship, Poland

Site Status

Univerzitna nemocnica Martin /ID# 147283

Martin, Žilina Region, Slovakia

Site Status

Hospital Universitario Vall d'Hebron /ID# 147288

Barcelona, , Spain

Site Status

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 147290

London, Greater London, United Kingdom

Site Status

Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292

London, Greater London, United Kingdom

Site Status

Countries

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United States Japan Poland Slovakia Spain United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://rxabbvie.com

This Clinical Study maybe evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.

Other Identifiers

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2015-001346-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-870

Identifier Type: -

Identifier Source: org_study_id

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