Maintenance Study of Certolizumab Pegol (CZP) in Crohn’s Disease
- Conditions
- Crohn’s DiseaseMedDRA version: 17.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2014-004354-34-Outside-EU/EEA
- Lead Sponsor
- CB Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Subjects who participated in main double-blind induction study C87037 [2014-004399-42] and showed clinical efficacy
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Subjects who experienced aggravation of Crohn’s disease during main double-blind induction study C87037 [2014-004399-42] and required treatment change
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method