Rheumatoid arthritis according to 2010 criteria
Conditions
Brief summary
The primary outcomes for the clinical effectiveness consists of 2 parts, namely the difference in (1) proportion of patients using a b- or tsDMARD after 10 months of treatment and (2) disease activity, measured with the disease activity score (DAS) over time. The primary outcome for the cost-effectiveness analysis will be the incremental cost-effectiveness ratio (ICER), which is the ratio of the difference in costs to incremental benefits between both management approaches.
Detailed description
Disease activity (states) at 10 months, measured with the DAS., To investigate whether (changes in) biomarker(s) (levels) can adequately predict treatment response., Self-reported disease activity, measured with the Routine Assessment of Patient Index Data 3 (RAPID3)., Morning stiffness (severity and duration), measured with a 10-point Likert scale., General Health, measured with a visual analogue scale (VAS, 0 – 100 mm), Fatigue, measured with a visual analogue scale (VAS, 0 – 100 mm), Pain, measured with Generalized Pain Questionnaire(GPQ) and PainDetect., Functional ability, measured with the health assessment questionnaire (HAQ)., Quality of life, measured with the Dutch EuroQol questionnaire with 5 dimensions (EQ-5D) with 5 levels., Patient satisfaction, compliance and patient participation is respectively measured with the the Treatment Satisfaction Questionnaire for Medication (TSQM) and VAS, the Medication Adherence Report Scale (MARS-5) and the 9-Item Shared Decision Making Questionnaire (SDMQ9)., The Impact on Participation and Autonomy questionnaire (IPAQ) focuses on autonomy and participation of patients with chronic conditions., Worker productivity, measured with the Work Productivity and Activity Impairment (WPAI) questionnaire, which includes presentism and absenteeism.
Interventions
DRUGMethotrexate 2
DRUGHydroxychloroquine sulfate 200mg film-coated Tablets
DRUGDepo-Medrol 80 mg/2 ml Injektionssuspension
DRUGLeflunomide Aurobindo 20 mg compresse rivestite con film
DRUGSulfasalazine 500 mg Tablets
DRUGKenacort-A 40
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes for the clinical effectiveness consists of 2 parts, namely the difference in (1) proportion of patients using a b- or tsDMARD after 10 months of treatment and (2) disease activity, measured with the disease activity score (DAS) over time. The primary outcome for the cost-effectiveness analysis will be the incremental cost-effectiveness ratio (ICER), which is the ratio of the difference in costs to incremental benefits between both management approaches. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease activity (states) at 10 months, measured with the DAS., To investigate whether (changes in) biomarker(s) (levels) can adequately predict treatment response., Self-reported disease activity, measured with the Routine Assessment of Patient Index Data 3 (RAPID3)., Morning stiffness (severity and duration), measured with a 10-point Likert scale., General Health, measured with a visual analogue scale (VAS, 0 – 100 mm), Fatigue, measured with a visual analogue scale (VAS, 0 – 100 mm), Pain, measured with Generalized Pain Questionnaire(GPQ) and PainDetect., Functional ability, measured with the health assessment questionnaire (HAQ)., Quality of life, measured with the Dutch EuroQol questionnaire with 5 dimensions (EQ-5D) with 5 levels., Patient satisfaction, compliance and patient participation is respectively measured with the the Treatment Satisfaction Questionnaire for Medication (TSQM) and VAS, the Medication Adherence Report Scale (MARS-5) and the 9-Item Shared Decision Making Qu | — |
Countries
Netherlands
Outcome results
None listed