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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02632175
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : February 5, 2020
Information provided by (Responsible Party):

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 (UC) Biological: Adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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 : November 26, 2015
Estimated Primary Completion Date : March 5, 2025
Estimated Study Completion Date : May 14, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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

Primary Outcome Measures :
  1. Proportion of subjects who achieve clinical remission as measured by PMS [ Time Frame: Up through Week 288 ]
    Clinical remission is defined as a PMS less than or equal to 2 and no individual sub score greater 1

  2. Proportion of subjects who achieve PUCAI response [ Time Frame: 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

  3. Proportion of subjects who achieve clinical response as measured by Partial Mayo Score (PMS) [ Time Frame: 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

  4. Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission [ Time Frame: Up through Week 288 ]
    PUCAI remission is defined as a score less than 10.

Secondary Outcome Measures :
  1. Assessing impact on children who have inflammatory bowel disease (ulcerative colitis) using IMPACT III questionnaire [ Time Frame: 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.

  2. Assessing activity impairment using the Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI: UC) [ Time Frame: Up through Week 288 ]
    Measures the impact of your child's UC on the parent/guardian's ability to work and perform regular activities.

  3. Proportion of subjects who achieve remission/response based on Full Mayo score [ Time Frame: 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:
  1. Mucosal Healing [ Time Frame: Up through Week 288 ]
    Mucosal Healing is defined as an endoscopy subscore of either 0 or 1.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02632175

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United States, Florida
Arnold Palmer Hosp Children /ID# 147295
Orlando, Florida, United States, 32806
United States, Minnesota
Minnesota Gastroenterology /ID# 147294
Minneapolis, Minnesota, United States, 55413
Mayo Clinic - Rochester /ID# 147304
Rochester, Minnesota, United States, 55905-0001
United States, Washington
MultiCare Institute Health Sys /ID# 169005
Tacoma, Washington, United States, 98405
Kurume University Hospital /ID# 145710
Kurume-shi, Fukuoka, Japan, 830-0011
Juntendo University Hospital /ID# 147315
Bunkyo-ku, Tokyo, Japan, 113-8431
National Center for Child Health and Development /ID# 147312
Setagaya-ku, Tokyo, Japan, 157-8535
Instytut Centrum Zdrowia Matki /ID# 169017
Lodz, Lodzkie, Poland, 93-338
Uni Szpital Dzieciecy w Krakowie /ID# 147279
Kraków, Malopolskie, Poland, 30-663
Centrum Zdrowia MDM /ID# 147280
Warsaw, Mazowieckie, Poland, 00-635
Gabinet Lekarski Bartosz Korcz /ID# 147281
Rzeszow, Poland, 35-210
Samodzielny Publiczny Szpital /ID# 147310
Wroclaw, Poland, 50-369
Univerzitna nemocnica Martin /ID# 147283
Martin, Zilinsky Kraj, Slovakia, 036 01
Hospital Univ Vall d'Hebron /ID# 147288
Barcelona, Spain, 08035
United Kingdom
The Royal London Hospital /ID# 147290
London, London, City Of, United Kingdom, E1 1BB
The Royal Free Hospital /ID# 147292
London, London, City Of, United Kingdom, NW3 2QG
Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie Identifier: NCT02632175    
Other Study ID Numbers: M10-870
2015-001346-29 ( EudraCT Number )
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.

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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
Keywords provided by AbbVie:
Ulcerative Colitis
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents
Antirheumatic Agents