Tofacitinib Registry of patients with ulcerative colitis in Germany
- Conditions
- K51Ulcerative colitis
- Registration Number
- DRKS00017740
- Lead Sponsor
- CED Service GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Patients with moderate to severe Ulcerative Colitis aged 18-80 years at enrollment
- Written informed consent is given
- New tofacitinib/biologics therapy started
Exclusion Criteria
- Malignant disease in history (except for non-melanoma skin cancer)
- Any contraindication according to the SmPC of the respective medication
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is steroid-free remission (remission: partial Mayo score = 1 plus a bleeding subscore of 0) in the inductionphase (week 16).
- Secondary Outcome Measures
Name Time Method 1. Online documentation of safety and efficacy in induction and maintenance therapy including the occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization)<br>2. Efficacy (response: partial Mayo Score reduction of = 3 accompanied by a decrease of at least 30% from baseline and remission: partial Mayo score = 1 plus a bleeding subscore of 0) of induction therapy (week 8 and 16) and maintenance therapy (months 6 to 24) and efficacy (response and remission) in different subpopulations, e.g. based on a previous biologic therapy or not.<br>3. Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (hospitalization, disability, treatment costs, quality of life, early retirement).<br>4. Obtaining data of the course from UC patients with a new therapy (Tofacitinib / biologics) related to treatment strategy and psychosocial impairments.