Hand Osteoarthritis
Conditions
Interventions
Treatment group:Iguratimod 25mg bid po.
Placebo group:Placebo 1 tablet bid po.
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 45 to 75 years; 2.Men or women; 3.Hand OA according to the ACR criteria; 4.Symptomatic interphalangeal osteoarthritis for more than 3 months (at least every other day); 5.At least 1 IPJ (DIP/PIP/IP1st) with soft tissue swelling or erythema; 6.At least 1 IPJ with positive power Doppler signal or/and synovial thickening of at least grade 2 on ultrasound; 7.Finger pain which was more than 40 mm as evaluated by visual analogue scales (VAS) (0-100 mm) in the preceding 48 hours; 8.Be able to adhere to the study visit schedule and other protocol requirements. Capable of giving informed consent and the consent must be obtained prior to any screening procedures.
Exclusion criteria
Exclusion criteria: 1.Other known medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, Lyme disease, Systemic lupus erythematosus, Sjogren Syndrome, Systemic sclerosis; 2.Psoriasis; 3.Involving carpometacarpal [CMC] joints, without interphalangeal joints; 4.Existence of painful syndrome of upper limbs likely to interfere with the monitoring of pain (cervicobrachial neuralgia, incapacitating carpal tunnel syndrome, joint disorders of the elbow or shoulder, poly-articular chondrocalcinosis, fibromyalgia); 5.Trigger finger, injury in joints within past 6 months; 6.Slow-acting drugs for OA (e.g. glucosamine, chondroitin, diacerhein) initiated within the previous 3 months before the study; 7.Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before screening; 8.Intra-articular corticosteroids into any joint or use of systemic corticosteroids 1 month before screening; 9.Treatment with analgesics initiated within the previous 1 month and NSAIDs initiated within the previous 2 weeks; 10.History of hand surgery within 12 months prior enrolment; 11.Participation in experimental device or experimental drug study 3 months prior to enrolment; 12.Scheduled surgery during study participation; 13.Pregnant or lactating womenplanned pregnancy within the study period, 3 months after end of study treatment for female fertile participant; 14.Known blood dyscrasias and coagulation disorders; 15.Elevated alanine transaminase (AST/ALT > 2x upper normal range); 16.GRF (MDRD) < 60 mg/min/1.73m^2; 17.Known viral hepatitis B or C; 18.Uncontrolled diseases, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids; 19.History of peptic ulcer; 20.Patients who have severe comorbidities, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, GI disease. Known any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as e.g. psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in joint pain after 12 weeks, assessed by a 100mm VAS scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in joint pain at 4, 8, and 12 weeks from baseline, assessed by a 100mm VAS scale;The change in AUSCAN (pain, stiffness and function, 5 point likert scale) at 4, 8, and 12 weeks from baseline;The change in FIHOA at 12 weeks from baseline;The change in HAQ at 12 weeks from baseline;The change in HAQ at 12 weeks from baseline;The change in MHOQ at 12 weeks from baseline;The difference of ultrasound scores at 12 weeks from baseline;The difference of MRI scores at weeks (n=20, 10 vs. 10), assessed by OMERACT hand OA MRI score; | — |
Countries
China
Contacts
Public ContactLi Zhanguo
Peking University People's Hospital
Outcome results
None listed