M06
Conditions
Interventions
Group 1: Adults diagnosed with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to, or are intolerant of, one or more disease-modifying antirheumatic drugs (DMAR
Sponsors
GWT-TUD GmbH, Innovationszentrum Real World Evidence
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients diagnosed with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to, or are intolerant of, one or more disease-modifying antirheumatic drugs (DMARDs). 2. Patients must be receiving treatment with Filgotinib (Jyseleca®) for the first time. Treatment must be in accordance with the approved product label. 3. Patients must be willing and able to use an electronic device to record patient-reported outcomes (PROs) during the study. 4. A written informed consent must be obtained prior to the first documentation.
Exclusion criteria
Exclusion criteria: Participation in an interventional study (inclusion in non-interventional studies or national registries is not precluded).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early benefit of filgotinib on pain, measured by the pain domain of the Rheumatoid Arthritis Impact of Disease (RAID) score (self-assessment by patient on diary) at week 4 or earlier, as absolute change compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To describe the baseline characteristics of patients receiving filgotinib, including socio-demographic characteristics, risk factors, reason for treatment initiation, RA disease characteristics, previous RA medications and reasons for treatment changes, comorbidities, and concomitant medications, and to compare these characteristics with patients who started filgotinib before and after label update (March 2023) • To evaluate the early benefit of filgotinib on inflammation measured with the DAS28 or CDAI at week 4 or earlier, compared to baseline • To evaluate the early benefit of filgotinib on fatigue measured by the fatigue domain of the RAID (self-assessment by patient on diary) at week 4 or earlier, as absolute and relative change compared to baseline • To describe effectiveness in filgotinib subgroups: naïve to advanced therapy (AT) versus AT-experienced, measured by RAID and DAS 28/CDAI and morning stiffness over time • To describe the effectiveness of filgotinib in patients newly started on filgotinib in this study compared to those who newly started filgotinib before and after label update (in March 2023) over the 24 weeks treatment duration, compared to baseline, measured by RAID and DAS 28/CDAI and morning stiffness • To describe the tolerability of filgotinib in patients newly started filgotinib put into perspective to those who started filgotinib before label update (in March 2023)– using FILOSOPHY as reference, assessed by the: Frequency, type and severity of - adverse drug reactions (ADR) - serious adverse drug reactions (SADR) - factually potential risks including serious and opportunistic infections (including herpes zoster), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), hyperlipidemia, malignancies, non-melanoma skin cancer (NMSC), and gastrointestinal (GI) perforation, fractures • To assess patient satisfaction (success, tolerability) with treatment on the VAS in patients newly started on filgotinib | — |
Countries
Austria, Germany
Contacts
Public ContactDavid Pittrow
GWT-TUD GmbH, Innovationszentrum Real World Evidence
Outcome results
None listed