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Sponsor: Assistance Publique - Hôpitaux de Paris
Conditions: Hand Osteoarthritis
Interventions: tocilizumab, saline solution
Countries: France
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.
Sex: ALL
Age: 40 Years to 85 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Age: 40-85 * Hand OA according to the ACR criteria (with recent X-rays of the hands - less than 6 months ) * Symptomatic hand OA lasting more than 3 months (DIP or PIP) despite analgesics and NSAIDs * OA affecting more than three finger joints (DIP or PIP) (Kellgren and Lawrence equal or more than 2) * Pain intensity superior to 40 (VAS 0-100 mm) in the last 24 hours * Not breastfeeding throughout the study and for 150 days after the last infusion * Negative pregnancy test or effective contraception for women of childbearing age throughout the study and for 150 days after the last infusion or postmenopausal or surgically sterile * Written informed consent * Affiliated to health system Exclusion Criteria: * Patients having already been treated with an anti-TNF alpha within 6 months * Patients having already been treated with an Interleukin-6-Receptor Inhibitor * Hand OA secondary to inflammatory rheumatism * Existence of painful syndrome of upper limbs likely to interfere with the monitoring of pain (cervicobrachial neuralgia, incapacitating carpal tunnel syndrome, joint disorders of the elbow or shoulder) * Inflammatory rheumatism * Psoriasis * Contraindications to Interleukin-6-Receptor Inhibitor * Contraindications to acetaminophen * Anticoagulant (oral) or treatment with heparin at a curative dose * Surgery scheduled within 6 months following recruitment * Local injection of a corticosteroid in a symptomatic finger joint during the previous month * Local injection of hyaluronic acid in a symptomatic finger joint during the prior 6 months * Treatment with a slow-acting anti-osteoarthritis agent initiated within the previous 3 months * Treatment with methotrexate, hydrochloroquine, sulfasalazine, colchicine within the last month * History of symptomatics sigmoiditis or intestinal ulceration * Oral corticosteroid within 3 days for hydrocortisone or cortisone, within 8 days for prednisone, prednisolone, methylprednisolone or triamcinolone, and within 12 days for betamethasone or dexamethasone * Psychiatric illness * Antidepressants initiated or modified within previous month * Non-controlled diabetes "mellitus" * Known viral hepatitis B or C, HIV infection * Current infectious (active or latent tuberculosis) * Excessive drinking * Participation in another search * Lidocain plasters on digital joint within two months
- Paris, Île-de-France Region, France