A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

• Register: EUCTR
• Last refreshed on: 20 July 2020
• Main ID: EUCTR2013-003032-77-GB
• Date of registration: 19/12/2013
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody 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: 30/10/2014
• Target sample size: 85
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003032-77
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, France, Hungary, Israel, Italy, New Zealand, Poland, Slovakia, Spain, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
? Subjects from the ages of 4 to 17 prior to baseline dosing.
? 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 85
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 TB


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): ? The proportion of subjects who achieve clinical remission at Week 8 as measured by PMS
? The proportion of subjects who responded at Week 8 per PMS and achieve clinical remission at Week 52 as measured by Mayo score

Main Objective: 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).

Secondary Objective: not applicable

Timepoint(s) of evaluation of this end point: Week 8, Week 52

Secondary Outcome(s)

Secondary end point(s): ? Proportion of subjects who achieve mucosal healing at Week 52 as measured by Mayo endoscopy subscore (defined as = 1) in Week 8 responders per PMS
? Proportion of subjects in PUCAI remission (defined as < 10) in Week 8 responders per PMS at Week 52

Timepoint(s) of evaluation of this end point: Week 52

Secondary ID(s)

M11-290

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 30/10/2014
Contact: