Real-World observational study on the health situation (QoL) and the psychosocial well-being of patients with ulcerative colitis under filgotinib therapy in the long-term course
- Conditions
- K51Ulcerative colitis
- Registration Number
- DRKS00027327
- Lead Sponsor
- CED Service GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 202
Inclusion Criteria
Patients with UC between the ages of 18 and 80 years at study inclusion.
Patients who are scheduled to receive new initiation therapy with filgotinib as determined by their treating physician.
Patients will be prescribed and receive therapy as part of the filgotinib subject information.
Optional additional scientific examination for motion profiles: availability of a personal smartphone.
Exclusion Criteria
A planned surgical intervention with inpatient hospital admission
A history of malignant disease (except for a Non-Melanoma Skin Cancer - NMSC)
Contraindications to therapy with filgotinib analogous to the SmPC
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The investigation of health status (QoL) and psychosocial well-being including exercise data in the real word setting in patients with ulcerative colitis in the long-term course in different disease phases is the primary endpoint.
- Secondary Outcome Measures
Name Time Method To collect patient-reported outcomes (PROs) related to quality of life (QoL) and psychomotor profiles (fatigue, depression) in patients with active ulcerative colitis at different disease stages during the long-term course.