Hand osteoarthritis (HOA) which affects the interphalangeal joints and the metacarpophalangeal of the thumb is a common disease, the prevalence of which being about 30 % of the population over than 70. Some forms of HOA are refractory to usual treatments (analgesics, NSAIDs, local injections) and can lead to a high disability. In vitro and in vivo studies showed that IL-6 is involved in the OA process. The aim of the present study is to assess the efficacy of an Interleukin-6-Receptor Inhibitor (tocilizumab) on pain and function in patients with refractory hand OA.
Patient is randomized to receive investigational product or placebo at week 0 and week 4 (1:1) * arm 1: 2 infusions four weeks apart of tocilizumab 8mg/kg * arm 2: 2 infusions four weeks apart of saline solution Follow-up visits are organized at week 6, and then week 8 and week 12. Primary outcome is the pain as assessed with the VAS at week 6. Secondary outcomes include morning stiffness duration, patient and practitioner global assessments, functional indexes for hand OA, number of painful joints, number of swollen joints. 110 patients is expected to be randomized in 36 months. Each patient sign an informed consent before the beginning of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.
La saline solution is administered by intravenous infusion.
Rheumatology department Lariboisiere Hospital
Paris, Île-de-France Region, France
Change of pain
Change of pain between the first infusion (week 0) and 2 weeks after the second infusion (week 6) as assessed on the VAS (0 -100 mm)
Time frame: 6 weeks
Change of pain
Change of pain between the first infusion (week 0) and 4, 8,12 weeks after the first infusion as assessed on the VAS (0 -100 mm)
Time frame: weeks 4, 8, 12
Number of painful joints
Time frame: weeks 4, 6, 8, 12
Number of swollen joints
Time frame: weeks 4, 6, 8, 12
Overall assessment of disability
Patient and practitioner global assessments
Time frame: weeks 4, 6, 8, 12
Morning stiffness duration
Time frame: weeks 4, 6, 8, 12
Evaluation of the function
Dreiser's algofunctional index + Functional Cochin hand index
Time frame: weeks 4, 6, 8, 12
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