Special drug use results surveillance for the use of SIMPONI in ulcerative colitis
Not Applicable
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000027542
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
Patients with a history of use of Golimumab (active ingredient of this product)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety analysis a. Onset status of adverse drug reactions including infectious events b. Onset status of serious adverse events c. Influencing factors d. Onset status of safety concerns and special interests e. Investigations on special populations (pediatric, elderly, pregnant/delivering/nursing women, patients with renal dysfunction, patients with hepatic dysfunction) Efficacy analysis a. Rate of responders b. Change in partial Mayo score c. Rate of clinical response d. Influencing factors e. Investigations on special populations (pediatric, elderly, pregnant/delivering/nursing women, patients with renal dysfunction, patients with hepatic dysfunction)
- Secondary Outcome Measures
Name Time Method