Hand osteoarthritis is one of the most common arthritis, resulting in pain in finger and thumb base joints. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. Currently limited therapy options are available. Synovial inflammation is involved in the joint pain. Iguratimod is a small disease-modifying compound that can influence anti-inflammatory pathways in models of rheumatoid arthritis. It has an anabolic effect on the bone metabolism of infected joint by osteoclastogenesis inhibition and osteoblast differentiation. The investigators hypothesize that Iguratimod will alleviate pain of patient with inflammatory hand osteoarthritis, and that a beneficial effect of Iguratimod on pain will be accompanied by a decrease of synovial inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
iguratimod, 25mg bid po.
placebo 1 tablet bid po.
Change from baseline in patient's assessment of arthritis pain on a visual analogue scale
Change from baseline in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 12 weeks of treatment; higher value indicate worse outcome.
Time frame: 12 weeks
Change from baseline in patient's assessment of arthritis pain on a visual analogue scale prior to each visit
Differences in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 4 weeks, 8 weeks, and 12 weeks; higher value indicate worse outcome.
Time frame: 4 weeks, 8 weeks, 12 weeks
Change from baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) scores at each visit.
The AUSCAN Index is a self-administered questionnaire consisting of a 15-item scale which measures pain (5 items), stiffness (1 item) and degree of disability/physical function (9 items) during the preceding 48 hours; higher value indicate worse outcome.
Time frame: 4 weeks, 8 weeks, 12 weeks
Change from baseline in Functional Index for Hand Osteoarthritis (FIHOA)
The Functional Index for Hand Osteoarthritis (FIHOA) is a leading assessment tool for hand OA-related functional impairment; higher value indicate worse outcome.
Time frame: 12 weeks
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ)
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ) at week 12; higher value indicate worse outcome.
Time frame: 12 weeks
Change from baseline in the Scores of SF-36 questionnaire
Change from baseline in SF-36, including physical and mental component sores (PCS and MCS) at week 12; higher value indicate worse outcome.
Time frame: 12 weeks
Change from baseline in Michigan Hand Outcomes Questionnaire (MHOQ)
Michigan Hand Outcomes Questionnaire (MHOQ) pain and physical function subscales; function subscale range 10-50, higher value indicate worse outcome; task subscale range 17-85, higher value indicate worse outcome; work subscale range 5-25, higher value indicate worse outcome; pain subscale range 10-48, higher value indicate better outcome.
Time frame: 12 weeks
Change from baseline in Ultrasound record
Ultrasound record: number of finger joints with synovial thickening and power Doppler signals.
Time frame: 12 weeks
Change from baseline in OMERACT hand OA magnetic resonance imaging score
OMERACT hand OA magnetic resonance imaging score includes synovitis (0-3), erosive damage(0-3), cyst (0-3), osteophyte (0-3), cartilage space loss(0-3), malalignment (0-3), and bone marrow lesions (0-3); higher value indicate worse outcome
Time frame: 12 weeks
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