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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00027327
Enrollment
250
Registered
2021-11-30
Start date
2021-12-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K51

Interventions

Group 1: Patients can participate in the study if they are receiving newly initiated therapy with Jyseleca (filgotinib) from their physician. The drug will be taken according to the valid professional

Sponsors

CED Service GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactSamantha Fajardo Salmon

CED Service GmbH

s.fajardo@ced-service.de025192870742

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026