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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iguratimod group | Active Comparator | subjects with Iguratimod |
|
| placebo group | Placebo Comparator | subjects with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iguratimod | Drug | iguratimod, 25mg bid po. |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks, 8 weeks, 12 weeks |
| Change from baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) scores at each visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Erythrocyte Sedimentation Rate (ESR) | Erythrocyte Sedimentation Rate (ESR); higher value indicate worse outcome. | 12 weeks |
| Change from baseline in C Reactive Protein (CRP) | C Reactive Protein (CRP); higher value indicate worse outcome. |
Inclusion criteria
Patients to be included must meet the following criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C519076 | iguratimod |
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| Drug |
placebo 1 tablet bid po. |
|
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. |
| 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. | 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. | 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. | 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. | 12 weeks |
| Change from baseline in Ultrasound record | Ultrasound record: number of finger joints with synovial thickening and power Doppler signals. | 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 | 12 weeks |
| 12 weeks |
| Change from baseline in patient's global assessment of disease activity on a visual analogue scale | Change from baseline in patient's global assessment of disease activity previous 48 hours on a 0-100 mm scale at 12 weeks of treatment; higher value indicate worse outcome. | 12 weeks |
| Change from baseline of physician's global assessment of disease activity on a visual analogue scale | Change from baseline in physician's global assessment of disease activity previous 48 hours on a 0-100 mm scale at 12 weeks of treatment; higher value indicate worse outcome. | 12 weeks |
| Change from baseline in Fingertip-to-palm distance | Change from baseline in Fingertip-to-palm distance, cm | 12 weeks |
| Change from baseline in grip strength | Change from baseline in grip strength, kg | 12 weeks |
| Swelling and Tender joint count, assessed by physician joint count | Swelling and Tender joint count, assessed by physician joint count | 12 weeks |