Rheumatoid Arthritis
Conditions
Interventions
None listed
Sponsors
Sint Maartenskliniek
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR and/or 1987 RA criteria and/or clini-cal diagnosis of treating rheumatologist (18;19) - Currently treated with either i.v. or s.c. tocilizumab in a dose of (162mg s.c. weekly/per 10 days/per 2 weeks/per 3 weeks or 8 to 4 mg/kg i.v. every 4 to 6 weeks) for at least 6 months - Stable low disease activity (DAS28-CRP16 years of age - Ability to read and communicate well in Dutch - Informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participa-tion in this study: - Previous non-response to sarilumab - Known relevant contraindications for sarilumab such as elevated liver enzymes, low leuko-cyte or platelet counts or active infection, as judged by the treating rheumatologist. - no ability to measure the study outcome (e.g. due to limited life expectancy or planned relocation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Increase in DAS28-CRP from baseline to month 6 compared to the pre-specified non-inferiority margin of 0.6 - Proportion of patients persisting with SRL treatment at month 6, compared to a pre-specified minimum persistence of 70% at month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: - DAS28-CRP at 0, 3, 6 months - CDAI at 0, 3, 6 months - Proportion of patients with a DAS28-CRP1.2 or a DAS28-CRP increase of >0.6 and current DAS28-CRP=2.9) - Mean disability as measured by HAQ-DI at 0, 3 and 6 months. Treatment strategy: - Treatment persistence: reasons for SRL discontinuation (e.g. lack of effect, adverse effects) - Use of comedication: corticosteroids (type, dose, start/stop dates) csDMARDs (type, dose, start/stop dates) and NSAIDs (start/stop dates) - Expectations of sarilumab efficacy from both patient and rheumatologist - Patient preference for tocilizumab or sarilumab and the reasons for this preference Safety: - Occurence of adverse events - We will register the occurrence of adverse events during the study period using the Common Toxicity Criteria for Adverse Events (CTCAE). Special attention will be given to the occurrence of infections and hypercholesterolaemia. - Routine safety monitoring of sarilumab, the following will be measured prior to sarilumab start, at week 4-8, and every 12 weeks thereafter: hemoglobin, leucocytes, thrombo-cytes, creatinine, alanine transaminase, alkaline phosphatase and a lipid profile Anti-drug antibodies and pharmacokinetics: - Proportion of patients with anti-drug antibodies (ADA) to tocilizumab at baseline - Proportion of patients with ADA to sarilumab at month 6 - Sarilumab levels at month 3 and month 6 and the time of sampling in relation to the last SRL injection Study integrity: - Reasons for dropout and protocol adherence | — |
Contacts
Public ContactNathan den Broeder
Sint Maartenskliniek
Outcome results
None listed