Clinical trial: The Nor-Hand Study (NCT03083548)

Eligibility criteria:
Inclusion Criteria:

          -  Age between 40-70 years at screening

          -  Proven hand OA by clinical examination and/or ultrasound

               1. Clinical examination criteria: Heberden/Bouchards nodes and/or bony enlargement,
                  squaring and/or deformity of the thumb base and no clinical signs of inflammatory
                  arthritis (e.g. soft tissue swelling of two or less metacarpophalangeal (MCP)
                  joints, and no soft tissue swelling of the wrist).

               2. Ultrasound criteria: Osteophytes in the interphalangeal joints and/or the thumb
                  base, and no signs of inflammatory arthritis (e.g. synovitis with power Doppler
                  activity in two or less MCP joints and no synovitis with power Doppler activity
                  in the wrist).

          -  Capable of understanding and signing an informed consent form

          -  Provided a written informed consent to participate in the study

        Exclusion Criteria:

          -  Diagnosis of inflammatory arthritic disease, e.g. seropositive or seronegative
             rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthritis or
             arthritis related to connective tissue disorders

          -  Diagnosis of psoriasis

          -  Erythrocyte sedimentation rate (ESR) > 40 mm/hour and/or C-reactive protein (CRP) >20
             mg/L, without a known ongoing infection

          -  Anti Cyclic Citrullinated Protein (anti-CCP) and/or rheumatoid factor positivity

          -  Ferritin >200 microgram/L for women and >300 microgram/L for men and s-iron/s-total
             iron binding capacity (TIBC) above 50%

          -  Major co-morbidities (e.g. severe malignancies, severe diabetes mellitus, severe
             infections, uncontrollable hypertension, severe cardiovascular disease or severe
             respiratory disease)

          -  Mental or psychiatric disorders, alcohol or drug abuse, language difficulties or other
             factors that make compliance to the study protocol difficult.
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 70 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