Clinical trial: Methotrexate in Erosive Inflammatory Hand Osteoarthritis (NCT04579848)

Eligibility criteria:
Inclusion Criteria:

          -  Finger joint pain 40-80 on 0-100 visual analog scale (VAS) with insufficient pain
             relief from, inability to tolerate or contra-indications to oral paracetamol and/or
             NSAIDs, and hand symptoms (pain, aching, or stiffness) on most days the previous 6
             weeks before randomization.

          -  Hand OA according to the American College of Rheumatology (ACR) criteria, at least 1
             distal (DIP) or proximal interphalangeal (PIP) joint of the 2nd-5th finger with
             radiographic pre-erosive (J-phase) or erosive disease (E-phase) according to the
             Verbruggen-Veys anatomical phase system, and at least two DIP/PIP joints with power
             Doppler signal of at least grade 1 or grey-scale synovitis of at least grade 2 on
             ultrasound.

        Exclusion Criteria:

        A full list of the exclusion criteria for this study comprised the following:

          -  Contraindications to methotrexate:

               -  Abnormal renal function, defined as serum creatinine >142 µmol/L in women and
                  >168 µmol/L in men, or a glomeruli filtration rate (GFR) <40 mL/min/1.73 m2.

               -  Abnormal liver function, defined as transaminases above the upper normal limit,
                  active or previous hepatitis B or C infection, or known cirrhosis

               -  Lung fibrosis (maximum 6 months old x-ray), active infection, or reduced
                  hematopoiesis (i.e. anemia, leukopenia and/or thrombocytopenia).

               -  Planned pregnancy within 18 months after screening (men/women), and pregnancy,
                  breastfeeding, or insufficient anti-conception therapy for female fertile
                  participants. Contraception should be maintained during treatment and until the
                  end of systemic exposure, i.e. 3 months after methotrexate discontinuation.
                  Sufficient anti-conception therapy consists of intra-uterine device (coil) or
                  hormonal anti-conception (birth control pills, implant, intra-uterine system,
                  dermal patch, vaginal ring, or injections).

               -  Alcohol or other drug abuse in the last year.

               -  Intolerance to lactose.

          -  Chronic inflammatory rheumatic diseases (such as rheumatoid arthritis and psoriatic
             arthritis or gout), active inflammatory bowel disease, or positive rheumatoid factor
             or anti-CCP antibodies.

          -  Other severe co-morbidities such as hemochromatosis, fibromyalgia, psoriasis, blood
             dyscrasias, and coagulation disorders, history of malignancy (except successfully
             treated squamous or basal cell skin carcinoma), uncontrolled diabetes mellitus, severe
             hypertension, unstable ischemic heart disease, severe heart failure, severe pulmonary
             disease, severe and/or opportunistic infections and/or chronic infections, active
             tuberculosis, positive human immunodeficiency virus (HIV) status, recent stroke, bone
             marrow hypoplasia, or demyelinating diseases of the central nervous system.

          -  Other likely causes of hand symptoms: thoracic outlet syndrome, carpal tunnel disease,
             diabetic cheiropathy, injury in finger joints previous 6 months, or palmar
             tenosynovitis/trigger finger.

          -  Oral or intra-muscular steroids in the previous month

          -  Intra-articular treatments or aspirations of any kind of any joint in the hands 3
             months before inclusion

          -  Analgesics or NSAIDs, unless stable dosage for ≥1 month.

          -  Symptomatic slow-acting drugs for OA (SYSADOA), unless stable dose for ≥3 months and
             require stable dose throughout the study.

          -  Disease-modifying osteoarthritis drugs (DMOADs) previous three months.

          -  Scheduled hand surgery during study participation.

          -  Planning to start other treatments for hand OA in the study participation period.

          -  Not able to adhere to the study visit schedule and protocol requirements.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? 1