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
- Conditions
- Crohns disease10017969
- Registration Number
- NL-OMON44363
- Lead Sponsor
- Mitsubishi Tanabe Pharma Europe Ltd (MTPE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>Safety, assessed by:<br /><br>* AEs<br /><br>* Vital signs<br /><br>* 12-lead ECG<br /><br>* Holter ECG monitoring<br /><br>* Routine safety laboratory assessments<br /><br>* Physical examination (including skin assessment)<br /><br>* Optical coherence tomography (OCT).</p><br>
- Secondary Outcome Measures
Name Time Method