Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis
Phase 3
- Conditions
- lcerative colitis
- Registration Number
- JPRN-jRCT2080220293
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
[Inclusion criteria]
Patients with active ulcerative colitis, who have failed to response, have failed to successfully taper or have medical complications to other existing medications, 16 years and above, male and female.
[Exclusion criteria]
Patients who have received infliximab in the past, have a history of serious infection which caused hospitalization within 6 months before the registration, have an active tuberculosis, have a complication or a history of malignancy within 5 years before the registration.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (clinical response), Safety and Pharmacokinetics
- Secondary Outcome Measures
Name Time Method