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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02632175
• Other study ID #: M10-870
• Secondary ID: 2015-001346-29
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 26, 2015
• Est. completion date: May 14, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: May 14, 2025
• Est. primary completion date: January 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• Adalimumab
every other week or weekly subcutaneous injection

Locations

Country	Name	City	State
Japan	Juntendo University Hospital /ID# 147315	Bunkyo-ku	Tokyo
Japan	Kurume University Hospital /ID# 145710	Kurume-shi	Fukuoka
Japan	National Center for Child Health and Development /ID# 147312	Setagaya-ku	Tokyo
Poland	Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279	Krakow	Malopolskie
Poland	Instytut Centrum Zdrowia Matki Polki /ID# 169017	Lodz	Lodzkie
Poland	Gabinet Lekarski Bartosz Korcz /ID# 147281	Rzeszow	Podkarpackie
Poland	Centrum Zdrowia MDM /ID# 147280	Warszawa	Mazowieckie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310	Wroclaw	Dolnoslaskie
Slovakia	Univerzitna nemocnica Martin /ID# 147283	Martin	Zilinsky Kraj
Spain	Hospital Universitario Vall d'Hebron /ID# 147288	Barcelona
United Kingdom	Barts Health NHS Trust /ID# 147290	London	London, City Of
United Kingdom	Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292	London	London, City Of
United States	MNGI Digestive Health, P. A. /ID# 147294	Minneapolis	Minnesota
United States	Arnold Palmer Hospital /ID# 147295	Orlando	Florida
United States	Mayo Clinic - Rochester /ID# 147304	Rochester	Minnesota
United States	MultiCare Institute Health System /ID# 169005	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Japan,  Poland,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mucosal Healing	Mucosal Healing is defined as an endoscopy subscore of either 0 or 1.	Up through Week 288
Primary	Proportion of subjects who achieve clinical remission as measured by PMS	Clinical remission is defined as a PMS less than or equal to 2 and no individual sub score greater 1	Up through Week 288
Primary	Proportion of subjects who achieve PUCAI response	PUCAI response is defined as a decrease in PUCAI greater than or equal to Up to 20 points from Study M11-290 Baseline	Up through Week 288
Primary	Proportion of subjects who achieve clinical response as measured by Partial Mayo Score (PMS)	Clinical response is defined as a decrease in PMS equal to or greater than 2 points and equal to or greater than 30% from Study M11-290 Baseline	Up through Week 288
Primary	Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission	PUCAI remission is defined as a score less than 10.	Up through Week 288
Secondary	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
Secondary	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
Secondary	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

External Links

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