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

NCT ID: NCT02477059

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-20
• Study Completion Date: 2019-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

tocilizumab

2 infusions four weeks apart

Group Type: EXPERIMENTAL

tocilizumab

Intervention Type: DRUG

Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.

saline solution

2 infusions four weeks apart

Group Type: PLACEBO_COMPARATOR

saline solution

Intervention Type: DRUG

La saline solution is administered by intravenous infusion.

Interventions

tocilizumab

Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.

Intervention Type: DRUG

saline solution

La saline solution is administered by intravenous infusion.

Intervention Type: DRUG

Other Intervention Names

ROACTEMRA®; NaCl 0,9 %

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richette Pascal, MD, PhD

Role: STUDY_DIRECTOR

Rheumatology department, Lariboisière Hospital

Locations

Rheumatology department Lariboisiere Hospital

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

P120206

Identifier Type: -

Identifier Source: org_study_id