EUCTR2014-004400-30-Outside-EU/EEAActive, not recruitingNot Applicable
A multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s Disease patients, who showed no clinical efficacy in a remission induction study (Study C87037) but showed clinical efficacy after additional remission induction therapy was applied, at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals
CB Japan Co., Ltd.0 sites46 target enrollmentStarted: February 27, 2015Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 46
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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