M06.8
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Experimental group: Filgotinib naive R.A., The patient is able to understand and give written, voluntary consent. Diagnosis of active RA and prescription of a new Filgotinib therapy by the treating rheumatologist. Partners: no rheumatic diseases, no treatment with DMARDs
Exclusion criteria
Exclusion criteria: Patient participates concurrently in another clinical trial. Known relevant heart, lung diseases or other medical contraindications that could influence the examination results. Patient is not able to participate due to any medical or psychological condition according to physician`s decision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show that treatment with Filgotinib restores physical participation in daily life in patients and in their partners as measured by a wrist accelerometer. The survey is conducted at 3 time points 1) before the start of treatment, 2) 12 and 3) 24 weeks after the start of therapy. Using a smartwatch, the number of steps is recorded over 7 consecutive days and thus the physical activity is measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| To show that treatment with Filgotinib reduces perceived levels of pain in patients as well as improving relationship satisfaction and psychological well-being in patients and in their partners. | — |
Countries
Germany
Contacts
Helios Fachklinik Vogelsang- Gommern