Clinical trial: Efficacy Study of an Anti-Tumor Necrosis Factor (TNF) Alpha Agent in Patients With Hand Osteoarthritis (NCT00597623)

Eligibility criteria:
Inclusion Criteria:

          -  Age: 40-80

          -  Men or women

          -  Digital osteoarthritis (DIP and PIP) according to ACR criteria (with recent X-ray,
             dating from less than 6 months, of the hands showing radiological signs of digital
             osteoarthritis)

          -  Symptomatic digital osteoarthritis for more than 3 months (at least every other day)
             despite taking analgesics and NSAIDs (except when there are contraindications to the
             latter therapeutic group)

          -  Osteoarthritis affecting more than three finger joints

          -  Pain more than 40 mm as evaluated by pain VAS (0-100 mm)

          -  No contraindication to anti-TNF alpha treatments

          -  No digital osteoarthritis surgery scheduled within the next 2 months

          -  Written informed consent

        Exclusion Criteria:

          -  Pregnant women or women of reproductive potential without effective contraception

          -  Known hypersensitivity

          -  Patients having already been treated with an anti-TNF alpha

          -  Finger osteoarthritis secondary to inflammatory rheumatism

          -  Psoriasis

          -  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

          -  Contraindications to anti-TNF alpha agents: patients with suspected reactivation of
             tuberculosis (phlyctenular IDR, past history of tuberculosis, chest X-ray deemed
             suspect) or known leukopenia (< 3500 leukocytes), known hepatic cytolysis
             (transaminases more than twice normal), a history of serious allergy, concomitant
             infection, past history of serious systemic infection (septicemia), a history of known
             cancer within the past 5 years, history of multiple sclerosis

          -  Skin disease incompatible with subcutaneous injection

          -  Anticoagulant (oral) or treatment with heparin at a curative dose

          -  Surgery scheduled within the coming 2 months

          -  Finger surgery scheduled within the coming 6 months

          -  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 3
             months

          -  Treatment with a slow-acting anti-osteoarthritis agent initiated and colchicine
             (amendment 26/06/2008) within the previous 3 months

          -  Oral corticosteroids

          -  Psychiatric illness

          -  Non-controlled diabetes "mellitus"

          -  Known viral hepatitis B or C, HIV infection
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 80 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