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

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

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Biological: Adalimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving Adalimumab<br>Subjects receiving Adalimumab up to 288 weeks | Biological: Adalimumab<br>* every other week or weekly subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis