Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02065557
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : August 13, 2018
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Biological: Adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Actual Study Start Date : October 15, 2014
Estimated Primary Completion Date : May 5, 2021
Estimated Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Adalimumab Dose A
0.6 mg/kg every other week (maximum of 40 mg every other week)
Biological: Adalimumab
Subcutaneous (SC) injection

Experimental: Adalimumab Dose B
0.6 mg/kg every other week (maximum of 40 mg every other week)
Biological: Adalimumab
Subcutaneous (SC) injection

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

  2. Proportion of subjects who achieve clinical remission [ Time Frame: Week 8 ]
    Measured by Partial Mayo Score (PMS)

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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

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).

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): NCT02065557

Contact: ABBVIE CALL CENTER 847.283.8955

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Sponsors and Collaborators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie Identifier: NCT02065557     History of Changes
Other Study ID Numbers: M11-290
2013-003032-77 ( EudraCT Number )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
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.

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.: Yes

Keywords provided by AbbVie:
Ulcerative Colitis

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