Clinical trial: Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Patients With Hand Osteoarthritis (NCT02477059)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment