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

NCT02632175 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M10-8702015-001346-29
• Study Type: interventional
• Target: 59
• Locations: 6 countries
• Sites: 16

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (5)

• 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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. 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: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. 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

Study Arms (1)

Subjects receiving Adalimumab

EXPERIMENTAL

Subjects receiving Adalimumab up to 288 weeks

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

every other week or weekly subcutaneous injection

Subjects receiving Adalimumab

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (16)

Arnold Palmer Hospital /ID# 147295

Orlando, Florida, 32806, United States

Location

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

Minneapolis, Minnesota, 55413-2195, United States

Location

Mayo Clinic - Rochester /ID# 147304

Rochester, Minnesota, 55905-0001, United States

Location

MultiCare Institute Health System /ID# 169005

Tacoma, Washington, 98405, United States

Location

Kurume University Hospital /ID# 145710

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Juntendo University Hospital /ID# 147315

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

National Center for Child Health and Development /ID# 147312

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279

Krakow, Lesser Poland Voivodeship, 30-663, Poland

Location

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

Wroclaw, Lower Silesian Voivodeship, 50-369, Poland

Location

Centrum Zdrowia MDM /ID# 147280

Warsaw, Masovian Voivodeship, 00-189, Poland

Location

Gabinet Lekarski Bartosz Korcz /ID# 147281

Rzeszów, Podkarpackie Voivodeship, 35-210, Poland

Location

Instytut Centrum Zdrowia Matki Polki /ID# 169017

Lodz, Łódź Voivodeship, 93-338, Poland

Location

Univerzitna nemocnica Martin /ID# 147283

Martin, Žilina Region, 036 01, Slovakia

Location

Hospital Universitario Vall d'Hebron /ID# 147288

Barcelona, 08035, Spain

Location

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

London, Greater London, E1 2ES, United Kingdom

Location

Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292

London, Greater London, NW3 2QG, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: November 26, 2015
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

ES (1); SL (1); GB (2); PL (5); US (4); JP (3)