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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Hand Osteoarthritis

Treatments

Drug: saline solution

Drug: tocilizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02477059

P120206

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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