Inflammatory arthritis (rheumatoid arthritis and psoriatic arthritis) Musculoskeletal Diseases Rheumatoid arthritis, unspecified, Other psoriatic arthropathies
Conditions
Interventions
Patients will be randomized using minimization randomization stratified for diagnosis and co-medication. Patients are randomized into morning or evening dosing of tofacitinib XR (11 mg q.d.) for 3 mon
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/11/2023: 1. Age =18 years 2. Diagnosed with rheumatoid arthritis (RA) or psoriatic arthritis (PsA), according to respectively the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for RA and ClASsification for Psoriatic ARthritis (CASPAR) criteria 3. Active disease, defined as a Disease Activity Score (DAS) >2.4 or Disease Activity in PSoriatic Arthritis (DAPSA) score >14 Previous inclusion criteria: 1. Age =18 years 2. Diagnosed with rheumatoid arthritis (RA) or psoriatic arthritis (PsA), according to respectively the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for RA and ClASsification for Psoriatic ARthritis (CASPAR) criteria 3. Active disease, defined as a Disease Activity Score (DAS) >2.4 or Disease Activity in PSoriatic Arthritis (DAPSA) score >14 4. Biological disease-modifying antirheumatic drug (bDMARD) usage <3
Exclusion criteria
Exclusion criteria: 1. Current or previous treatment with a targeted synthetic (ts)DMARD 2. Prednisone (or equivalent) at a dose of >7.5 mg 3. (Relative) contraindications for the study medication 4. Work in shifts 5. Not being able to understand, speak and write in Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity measured with the Routine Assessment of Patient Index Data 3 (RAPID3) at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/11/2023: 1. (Self-reported) disease activity (states) measured using Disease Activity Score (DAS) & Disease activity in PSoriatic Arthritis (DAPSA) at 3 and 6 months 2. Sleep measured using a sleep scale from the medical outcomes study (MOSS-ss) at 3 and 6 months 3. Morning stiffness (severity and duration) measured using a 10-point Likert scale at 3 and 6 months 4. Pain measured using a visual analogue scale (VAS) and the generalized pain questionnaire (GPQ) at 3 and 6 months 5. Fatigue measured using a visual analogue scale (VAS) and the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at 3 and 6 months 6. General health measured using a visual analogue scale (VAS) at 3 and 6 months 7. Functional ability measured using the health assessment questionnaire disability index (HAQ-DI) at 3 and 6 months 8. Quality of life measured using EuroQoL (EQ-5D-5L) at 3 and 6 months 9. Worker productivity measured using the Work Productivity and Activity Impairment (WPAI) at 3 and 6 months 10. Treatment satisfaction measured using a visual analogue scale (VAS) at 3 and 6 months 11. Compliance measured using the Medication Adherence Report Scale (MARS-5) at 3 and 6 months Previous secondary outcome measures: 1. (Self-reported) disease activity (states) measured using Disease Activity Score (DAS) & Disease activity in PSoriatic Arthritis (DAPSA) at 3 and 6 months 2. Sleep measured using a sleep scale from the medical outcomes study (MOSS-ss) at 3 and 6 months 3. Morning stiffness (severity and duration) measured using a 10-point Likert scale at 3 and 6 months 4. Pain measured using a visual analogue scale (VAS) at 3 and 6 months 5. Fatigue measured using a visual analogue scale (VAS) and the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at 3 and 6 months 6. General health measured using a visual analogue scale (VAS) at 3 and 6 months 7. Functional ability measured using the health assessment que | — |
Countries
Netherlands
Contacts
Public ContactSelinde Snoeck Henkemans
Outcome results
None listed