Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (2014-004399-42)
- 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
- EUCTR2014-004400-30-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
- 46
Inclusion Criteria
Subjects who gave written informed consent and who did not show clinical efficacy at Week 6 of the double-blind main study (2014-004399-42) [reduction in Crohn's Disease Activity Index (CDAI) score of =100 points from Week 0, or remission (CDAI =150)]
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
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 the double-blind main study (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