A non-interventional, prospective study to evaluate change in physical activity, relationship satisfaction and psychological well-being in patients with rheumatoid arthritis after introduction of the JAK inhibitor filgotinib and also in their partners.
- Conditions
- M06.8Other specified rheumatoid arthritis
- Registration Number
- DRKS00032128
- Lead Sponsor
- Helios Fachklinik Vogelsang-Gommern, Rheumatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To show that treatment with Filgotinib restores physical participation in daily life in patients and in their partners as measured by a wrist accelerometer.<br><br>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 Outcome Measures
Name Time Method 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.