Handscan optical measurements in Rheumatoid Arthritis: an inventory comparing serum levels of CRP, ESR, IL-6, clinical arthritis and reproducibility of DAS28.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 45

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
- At least two swollen joints of wrists, PIP or MCP joints.
- No previous methotrexate and/or biologic treatment
- No systemic steroids within 6 weeks prior to baseline

Exclusion Criteria

- Deformity of the hand or an allergy to light is an exclusion criteria for
valid use of the Handscan
- A recent (< 2 months) or planned carpal tunnel operation
- Female who is pregnant, breastfeeding, or is considering becoming pregnant
during
the study or a male planning to father a child.
- Any active or recurrent viral infection that, based on the Investigator's
clinical
assessment, makes the subject an unsuitable candidate for the study, including
hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated
(even a single episode) herpes zoster, disseminated (even a single episode)
herpes
simplex, or human immunodeficiency virus (HIV).
- History of any malignancy within the last five years except for successfully
treated NMSC or localized carcinoma in situ of the cervix.
- Laboratory values meeting the following criteria within the Screening period
prior
to the first dose of study drug:
Serum aspartate transaminase (AST) > 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity to change of the Handscan during consecutive visits after<br /><br>initiation of different treatment strategies. In this, the percentage of<br /><br>patients with an initial response detected by the Handscan ( = at least 2<br /><br>points reduction in TOS) at the different moments in time will be determined (%<br /><br>initial response at week 1 (early), week 3 (early), week 6 (intermediate), week<br /><br>9 (late), week 12 ( late), respectively). </p><br>

Secondary Outcome Measures