Overview

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