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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT02632175
• Date of registration: 14/12/2015
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public title: Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
• Scientific 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
• Date of first enrolment: November 26, 2015
• Target sample size: 59
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02632175
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion 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



Age minimum: 4 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

Proportion of subjects who achieve clinical remission as measured by PMS [Time Frame: Up through Week 288]

Proportion of subjects who achieve PUCAI response [Time Frame: Up through Week 288]

Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission [Time Frame: Up through Week 288]

Proportion of subjects who achieve clinical response as measured by Partial Mayo Score (PMS) [Time Frame: Up through Week 288]

Secondary Outcome(s)

Proportion of subjects who achieve remission/response based on Full Mayo score [Time Frame: Up through Week 288]

Assessing activity impairment using the Work Productivity and Activity Impairment Questionnaire: Ulcerative Colitis (WPAI: UC) [Time Frame: Up through Week 288]

Assessing impact on children who have inflammatory bowel disease (ulcerative colitis) using IMPACT III questionnaire [Time Frame: Up through Week 288]

Secondary ID(s)

2015-001346-29

M10-870

Source(s) of Monetary Support

Please refer to primary and secondary sponsors