Rheumatoid Arthritis
Conditions
Interventions
Early MTX naive RA patients will be randomized in three subgroups: I. methotrexate monotherapy, II. methotrexate plus depomedrol and III. methotrexate plus Sarilumab.
After randomisation the study is
Sponsors
Investigator initiated via Leiden University Medical Center (LUMC) department of Rheumatology with a grant from Sanofi with no conditions set
Eligibility
Inclusion criteria
Inclusion criteria: - Able and willing to give written informed consent - Patients aged =18 years - Recent (< 2 yr) diagnosis of Rheumatoid Arthritis (RA) according to the 2010 American College of Rheumatology/European League Against Rheumatism (EULAR/ACR) classification criteria (8) - At least two swollen joints of wrists, PIP or MCP joints. - No previous methotrexate and/or biologic treatment - No systemic steroid within 6 weeks prior to baseline
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Deformity of the hand or an allergy to light is an exclusion criteria for valid use of the Handscan - A recent ( 2 × ULN Serum alanine transaminase (ALT) > 2 × ULN Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73 m2 Total white blood cell (WBC) count < 2,500/µL Absolute neutrophil count (ANC) < 1,500/µL Platelet count < 100,000/µL Absolute lymphocyte count < 850/µL Hemoglobin < 5.8 mmol/L - Uncooperative patients, or any condition that could make the patient potentially noncompliant to the study procedures - Patients for whom Sarilumab is contra-indicated as described in the local label - Patients currently participating in any interventional clinical trials - Previous experience with Sarilumab either through a clinical trial or treatment - Concomitant use of any biologic DMARDs or any tsDMARDs, including but not limited to etanercept, adalimumab, infliximab, anakinra, rituximab, abatacept, tociluzumab, certolizumab, golimumab, tofacitinib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity to change of the Handscan during consecutive visits after initiation of different treatment strategies. In this, the percentage of patients with an initial response detected by the Handscan ( = at least 2 points reduction in TOS) at the different moments in time will be determined (% initial response at week 1 (early), week 3 (early), week 6 (intermediate), week 9 (late), week 12 ( late), respectively). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Sensitivity to change of the currently used parameters SJC, TJC, DAS28, CRP, BSE and IL-6 during the consecutive visits after initiation of different treatment strategies. In this, the same endpoint parameter will be used with the applicable response definition for each of the instruments. - Difference in response time between Handscan response detection and response detection by the currently used instruments. Differences will be categorized as within patient difference in response time (Handscan response x weeks earlier to x weeks later) - Handscan TOS and SJC, TJC, DAS28, CRP, BSE and IL-6 at baseline and during the consecutive visits. - Defining the Handscan optical scores in untreated early RA patients at baseline - Establish reproducibility of Handscan measurements with interobserver variability of DAS28 - Association between Handscan total optical score and DAS28 - Describing the effects of Sarilumab therapy in MTX naïve patients compared to the monotherapy MTX group - Establish IL-6 levels with rate of severity of arthritis activity, DAS28 categories | — |
Contacts
Public Contactflorentina reimann
Rheumatology Research Center Northern Netherlands at Medical Center Leeuwarden
Outcome results
None listed