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

Conditions

• Hand Osteoarthritis

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Nov 20, 2015

Status verified

Jul 2019

Primary completion

Dec 26, 2018

Completion

Feb 28, 2019

Study Design

Enrollment

104 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: tocilizumab
  2 infusions four weeks apart
• Placebo Comparator: saline solution
  2 infusions four weeks apart

Primary Outcome Measure

Change of pain [ Time Frame: 6 weeks ]