A Multi-Center, Open-Label Study of 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

• Register: EUCTR
• Last refreshed on: 9 October 2017
• Main ID: EUCTR2015-001346-29-GB
• Date of registration: 28/09/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Multi-Center, Open-Label Study of 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
• 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: 08/02/2016
• Target sample size: 93
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001346-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Open label extension study If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, Czech Republic, European Union, Hungary, Israel, Japan, New Zealand, Spain, Sweden, 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:
Subject must have successfully enrolled in and completed Protocol M11-290 through Week 52.
Are the trial subjects under 18? yes
Number of subjects for this age range: 93
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for continuing therapy in the Study M10-870.


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

Health Condition(s) or Problem(s) studied

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

Ulcerative Colitis
MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000016670

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: 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-

Primary Outcome(s)

Secondary Objective: Not applicable

Main Objective: The objective of the study is to evaluate the long-term safety, tolerability, and maintenance of clinical response, of repeated administration of adalimumab in pediatric subjects with ulcerative colitis who participated in, and successfully completed, Protocol M11-290 through Week 52.

Primary end point(s): This study will utilize the PMS (and Mayo score if available) and PUCAI to determine efficacy of the study drug

Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 108, 120, 144, 168, 192, 216, 240, 264 and 288/Premature Discontinuation

Secondary Outcome(s)

Secondary end point(s): Safety analyses will be performed on all subjects who receive at least one dose of study drug.

Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288/Premature Discontinuation

Secondary ID(s)

2015-001346-29-BE

M10-870

Source(s) of Monetary Support

AbbVie Deutschland GmbH & Co. KG