Back to resultsLong-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis
Eligibility Criteria
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
Sites / Locations
- Arnold Palmer Hospital /ID# 147295
- MNGI Digestive Health, P. A. /ID# 147294
- Mayo Clinic - Rochester /ID# 147304
- MultiCare Institute Health System /ID# 169005
- Kurume University Hospital /ID# 145710
- Juntendo University Hospital /ID# 147315
- National Center for Child Health and Development /ID# 147312
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310
- Instytut Centrum Zdrowia Matki Polki /ID# 169017
- Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279
- Centrum Zdrowia MDM /ID# 147280
- Gabinet Lekarski Bartosz Korcz /ID# 147281
- Univerzitna nemocnica Martin /ID# 147283
- Hospital Universitario Vall d'Hebron /ID# 147288
- Barts Health NHS Trust /ID# 147290
- The Royal Free London NHS Foundation Trust /ID# 147292
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects receiving Adalimumab
Arm Description
Subjects receiving Adalimumab up to 288 weeks
Outcomes
Primary Outcome Measures
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
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
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
Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission
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
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02632175
Brief Title
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2015 (Actual)
Primary Completion Date
January 20, 2025 (Anticipated)
Study Completion Date
May 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving Adalimumab
Arm Type
Experimental
Arm Description
Subjects receiving Adalimumab up to 288 weeks
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Intervention Description
every other week or weekly subcutaneous injection
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve clinical remission as measured by PMS
Description
Clinical remission is defined as a PMS less than or equal to 2 and no individual sub score greater 1
Time Frame
Up through Week 288
Title
Proportion of subjects who achieve PUCAI response
Description
PUCAI response is defined as a decrease in PUCAI greater than or equal to Up to 20 points from Study M11-290 Baseline
Time Frame
Up through Week 288
Title
Proportion of subjects who achieve clinical response as measured by Partial Mayo Score (PMS)
Description
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
Time Frame
Up through Week 288
Title
Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission
Description
PUCAI remission is defined as a score less than 10.
Time Frame
Up through Week 288
Secondary Outcome Measure Information:
Title
Assessing impact on children who have inflammatory bowel disease (ulcerative colitis) using IMPACT III questionnaire
Description
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.
Time Frame
Up through Week 288
Title
Assessing activity impairment using the Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI: UC)
Description
Measures the impact of your child's UC on the parent/guardian's ability to work and perform regular activities.
Time Frame
Up through Week 288
Title
Proportion of subjects who achieve remission/response based on Full Mayo score
Description
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.
Time Frame
Up through Week 288
Other Pre-specified Outcome Measures:
Title
Mucosal Healing
Description
Mucosal Healing is defined as an endoscopy subscore of either 0 or 1.
Time Frame
Up through Week 288
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Arnold Palmer Hospital /ID# 147295
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
MNGI Digestive Health, P. A. /ID# 147294
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55413-2195
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 147304
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
MultiCare Institute Health System /ID# 169005
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Kurume University Hospital /ID# 145710
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Juntendo University Hospital /ID# 147315
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
National Center for Child Health and Development /ID# 147312
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-369
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki /ID# 169017
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Centrum Zdrowia MDM /ID# 147280
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Gabinet Lekarski Bartosz Korcz /ID# 147281
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-210
Country
Poland
Facility Name
Univerzitna nemocnica Martin /ID# 147283
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Hospital Universitario Vall d'Hebron /ID# 147288
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Barts Health NHS Trust /ID# 147290
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
The Royal Free London NHS Foundation Trust /ID# 147292
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
http://rxabbvie.com
Description
This Clinical Study maybe evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.
Learn more about this trial
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
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