Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Hoffmann-La Roche
• Treatments: Pharmaceutical Solutions

Criteria

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