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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02065557
First received: February 17, 2014
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

Condition Intervention Phase
Ulcerative Colitis
Biological: Adalimumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of subjects who achieve clinical remission [ Time Frame: Week 8 ]
    Measured by Partial Mayo Score (PMS)

  • Proportion of subjects who responded at Week 8 per PMS and achieve clinical remission [ Time Frame: Week 52 ]
    Measured by Mayo score


Secondary Outcome Measures:
  • Proportion of subjects who achieve mucosal healing [ Time Frame: Week 52 ]
    Measured by Mayo endoscopy subscore (defined as ≤ 1) in Week 8 responders per PMS

  • Proportion of subjects in Pediatric Ulcerative Colitis Activity Index (PUCAI) remission [ Time Frame: Week 52 ]
    Measured by PUCAI remission (defined as < 10) in Week 8 responders per PMS


Estimated Enrollment: 245
Study Start Date: October 13, 2014
Estimated Study Completion Date: July 15, 2021
Estimated Primary Completion Date: June 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Adalimumab
Induction period Maintenance period
Biological: Adalimumab
Subcutaneous (SC) injection
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Ulcerative Colitis (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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065557

Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

  Show 79 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Andreas Lazar AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02065557     History of Changes
Other Study ID Numbers: M11-290
2013-003032-77 ( EudraCT Number )
Study First Received: February 17, 2014
Last Updated: April 14, 2017

Keywords provided by AbbVie:
Ulcerative Colitis
adalimumab

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 26, 2017