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

Sponsor

AbbVie (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02632175

Collaborator

(none)

101

Enrollment

Locations

Arm

113.6

Anticipated Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Biological: Adalimumab	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

101 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 26, 2015

Anticipated Primary Completion Date :

May 14, 2025

Anticipated Study Completion Date :

May 14, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Subjects receiving Adalimumab

Subjects receiving Adalimumab up to 288 weeks

Biological: Adalimumab

every other week or weekly subcutaneous injection

Outcome Measures

Primary Outcome Measures

Proportion of subjects who achieve clinical remission as measured by PMS [Up through Week 288]
Clinical remission is defined as a PMS less than or equal to 2 and no individual sub score greater 1
Proportion of subjects who achieve PUCAI response [Up through Week 288]
PUCAI response is defined as a decrease in PUCAI greater than or equal to Up to 20 points from Study M11-290 Baseline
Proportion of subjects who achieve clinical response as measured by Partial Mayo Score (PMS) [Up through Week 288]
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
Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission [Up through Week 288]
PUCAI remission is defined as a score less than 10.

Secondary Outcome Measures

Assessing impact on children who have inflammatory bowel disease (ulcerative colitis) using IMPACT III questionnaire [Up through Week 288]
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.
Assessing activity impairment using the Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI: UC) [Up through Week 288]
Measures the impact of your child's UC on the parent/guardian's ability to work and perform regular activities.
Proportion of subjects who achieve remission/response based on Full Mayo score [Up through Week 288]
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.

Other Outcome Measures

Mucosal Healing [Up through Week 288]
Mucosal Healing is defined as an endoscopy subscore of either 0 or 1.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arnold Palmer Hospital /ID# 147295	Orlando	Florida	United States	32806
2	MNGI Digestive Health, P. A. /ID# 147294	Minneapolis	Minnesota	United States	55413-2195
3	Mayo Clinic - Rochester /ID# 147304	Rochester	Minnesota	United States	55905-0001
4	MultiCare Institute Health System /ID# 169005	Tacoma	Washington	United States	98405
5	Kurume University Hospital /ID# 145710	Kurume-shi	Fukuoka	Japan	830-0011
6	Juntendo University Hospital /ID# 147315	Bunkyo-ku	Tokyo	Japan	113-8431
7	National Center for Child Health and Development /ID# 147312	Setagaya-ku	Tokyo	Japan	157-8535
8	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310	Wroclaw	Dolnoslaskie	Poland	50-369
9	Instytut Centrum Zdrowia Matki Polki /ID# 169017	Lodz	Lodzkie	Poland	93-338
10	Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279	Krakow	Malopolskie	Poland	30-663
11	Centrum Zdrowia MDM /ID# 147280	Warszawa	Mazowieckie	Poland	00-635
12	Gabinet Lekarski Bartosz Korcz /ID# 147281	Rzeszow	Podkarpackie	Poland	35-210
13	Univerzitna nemocnica Martin /ID# 147283	Martin		Slovakia	036 01
14	Hospital Universitario Vall d'Hebron /ID# 147288	Barcelona		Spain	08035
15	Barts Health NHS Trust /ID# 147290	London	London, City Of	United Kingdom	E1 2ES
16	The Royal Free London NHS Foundation Trust /ID# 147292	London	London, City Of	United Kingdom	NW3 2QG

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT02632175

Other Study ID Numbers:

M10-870
2015-001346-29

First Posted:

Dec 16, 2015

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

Ulcerative Colitis

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022