NCT02477059

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

Double-blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Two Infusions Four Weeks Apart of Interleukin-6-Receptor Inhibitor (Tocilizumab) on Pain Relief in Patients With Severe Osteoarthritis of the Hand Refractory to Usual Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hand Osteoarthritis

Interventions

Type	Name	Description
DRUG	tocilizumab	Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.
DRUG	saline solution	La saline solution is administered by intravenous infusion.

Timeline

• Start date: 2015-11-20
• Primary completion: 2018-12-26
• Completion: 2019-02-01
• First posted: 2015-06-22
• Last updated: 2019-07-30

Locations

1 site across 1 country: France