None listed
Conditions
Brief summary
Hand osteoarthritis (OA) is a disabling condition impeding activity of daily living leading to pain, functional impairment, and reduced quality of life. The age-standardised prevalence of hand OA in the general population is 44·2% in women and 37·7% in men. Despite the high prevalence and significant disease burden, there is no effective therapy for hand OA. Hand OA is a heterogeneous condition. The inflammatory phenotype is a commonly encountered clinical phenotype, characterized by joint swelling (synovitis). The presence of synovitis being associated with joint pain and structural progression. Therefore, synovitis has the potential to be a target for treatment in hand OA. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. In our previous METHODS study (a randomized, double-blind, placebo-controlled trial to determine the effect of 20 mg methotrexate once weekly on reducing pain and improving function in patients with symptomatic hand OA and synovitis over 6 months, ACTRN12617000877381), we showed that methotrexate would reduce pain and stiffness over 6 months compared to placebo in patients with hand OA and synovitis. But there are still a number of unknown questions regarding the use of methotrexate, including how long we need to treat those with hand OA with methotrexate; is there a group that are more likely to respond; and does response to treatment predict less joint damage. Thus, we conducted this METHODS-Extend open label study to address those queries.
Interventions
Methotrexate
- the dose administered: 10 mg weekly for four weeks, followed by 20 mg weekly for four weeks, and then increased to 25mg weekly for the remainder of the study if there is no toxicity as determined at the physician’s discretion (Australian Rheumatology Association Guidelines)
- the duration of administration: 12 months
- the mode of administration: oral tablet
All participants will be prescribed oral folic acid at a minimum dose of 5 mg/week, 6 days/week.
Pill count will be perfor
Methotrexate - the dose administered: 10 mg weekly for four weeks, followed by 20 mg weekly for four weeks, and then increased to 25mg weekly for the remainder of the study if there is no toxicity as determined at the physician’s discretion (Australian Rheumatology Association Guidelines) - the duration of administration: 12 months - the mode of administration: oral tablet All participants will be prescribed oral folic acid at a minimum dose of 5 mg/week, 6 days/week. Pill count will be performed at 4 weeks, 3, 6, 9 and 12 months to monitor adherence.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 40 - 75 years 2. Pain in the hand joints for most days in the last 6 weeks and a pain score of at least 40 on a 100 mm visual analogue scale (VAS) in the last 7 days, hand osteoarthritis that fulfilled the American College of Rheumatology criteria, and radiological osteoarthritis (Kellgren and Lawrence grade greater than or equal to 2) in at least one joint.
Exclusion criteria
(1) concomitant rheumatic disease, inflammatory joint disease, psoriatic arthritis, ankylosing spondylitis, gout, psoriasis, or suspected chondrocalcinosis; positive rheumatoid factor or anti-cyclic citrullinated peptides, elevated C-reactive protein of > 2X upper limit of normal. (2) contraindication to methotrexate [e.g. renal, liver or haematological condition, cancer including skin cancer, serious infections requiring hospitalisation in the last 5 years, known or past infection with human immunodeficiency virus, hepatitis B or C, tuberculosis, or known lung disease with scarring (any fibrosis or evidence of past tuberculosis exposure on chest x-ray), taking regular trimethoprim or trimethoprim/sulfamethoxazole antibiotics, egg or flu vaccination allergy] (3) unable to complete informed consent (4) women who are pregnant, breast-feeding or trying to become pregnant, or men who planned to father a child (5) excessive alcohol intake
Outcome results
None listed