EUCTR2014-002557-19-PLActive, not recruitingPhase 1
A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study
Mitsubishi Tanabe Pharma Corporation (MTPC)0 sites80 target enrollmentStarted: January 21, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. The subject completed the 14 week Treatment Period in the double-blind MT-1303-E13 study as per Protocol.
- •2. The subject is able to provide written informed consent and to comply with the requirements of the MT-1303-E14 Protocol during the study.
- •3. For subjects of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
- •For detailed information, please refer to the Protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 79
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
- •1. Permanent discontinuation of study medication prior to the EOT Visit in MT-1303-E13
- •2. Newly diagnosed diabetes mellitus during the double blind MT-1303-E13 study.
- •For detailed information, please refer to the Protocol.
Investigators
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