Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02065557
• Date of registration: 17/02/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
• Scientific title: A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
• Date of first enrolment: October 13, 2014
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02065557
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Czechia, Hungary, Israel, Italy, Japan, New Zealand, Poland, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with
biopsy.

- Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of
2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or
both.

Exclusion Criteria:

- Subject with Crohn's disease (CD) or indeterminate colitis (IC).

- Current diagnosis of fulminant colitis and/or toxic megacolon.

- Subjects with disease limited to the rectum (ulcerative proctitis) during the
screening endoscopy.

- Chronic recurring infections or active tuberculosis (TB).



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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Biological: Adalimumab

Biological: Placebo

Primary Outcome(s)

Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period [Time Frame: Week 8]

Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period [Time Frame: Week 52]

Secondary Outcome(s)

Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period [Time Frame: Week 52]

Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period [Time Frame: Week 52]

Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period [Time Frame: Week 52]

Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period [Time Frame: Week 52]

Secondary ID(s)

2013-003032-77

M11-290

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02065557