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

A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Biological: Adalimumab

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 145710
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital /ID# 147315
    • Setagaya-ku, Tokyo, Japan, 157-8535
      • National Center for Child Health and Development /ID# 147312
• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-663
      • Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-369
      • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-189
      • Centrum Zdrowia MDM /ID# 147280
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-210
      • Gabinet Lekarski Bartosz Korcz /ID# 147281
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 93-338
      • Instytut Centrum Zdrowia Matki Polki /ID# 169017
• Slovakia
  • Žilina Region
    • Martin, Žilina Region, Slovakia, 036 01
      • Univerzitna nemocnica Martin /ID# 147283
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 147288
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, NW3 2QG
      • Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292
    • London, Greater London, United Kingdom, E1 2ES
      • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 147290
• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Arnold Palmer Hospital /ID# 147295
  • Minnesota
    • Minneapolis, Minnesota, United States, 55413-2195
      • MNGI Digestive Health, P. A. /ID# 147294
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 147304
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute Health System /ID# 169005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects receiving Adalimumab; Subjects receiving Adalimumab up to 288 weeks	Biological: Adalimumab; every other week or weekly subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.	From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks).
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS)	The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease). The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1.	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline)	The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease). The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical response was defined as a decrease in PMS ≥ 2 points and ≥ 30% from Study M11-290 Baseline.	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission	The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). Clinical remission was defined as a PUCAI score < 10.	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline)	The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). PUCAI response was defined as a decrease in PUCAI score ≥ 20 points from Study M11-290 Baseline.	Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing impact on children who have inflammatory bowel disease (ulcerative colitis) using IMPACT III questionnaire	This is a 35 item, self-administered questionnaire, with total score ranging from 35 (poor) to 175 (best). The questions are about the quality of the child's life with inflammatory bowel disease.	Up through Week 288
Assessing activity impairment using the Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI: UC)	Measures the impact of your child's UC on the parent/guardian's ability to work and perform regular activities.	Up through Week 288
Proportion of subjects who achieve remission/response based on Full Mayo score	Full Mayo score will be based on subjects with available Full Mayo score data. Full Mayo score is a composite of 4 subscores. Each subscore is a number from 0 (lowest) to 3 (highest) with a total score of 0-12. Clinical remission per Full Mayo Score is defined as a Full Mayo Score less than or equal to 2 and no individual subscore greater than 1. Clinical response per Full Mayo Score defined as a decrease in Full Mayo Score greater than or equal to 3 points and greater than or equal to 3 points 30% from Baseline.	Up through Week 288

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal Healing	Mucosal Healing is defined as an endoscopy subscore of either 0 or 1.	Up through Week 288

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2015
• Primary Completion (Actual): April 8, 2025
• Study Completion (Actual): April 8, 2025

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimated): December 16, 2015

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative Colitis
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Adalimumab
• Other Study ID Numbers: M10-870; 2015-001346-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No