Prospective, randomised, double-blind, placebo-controlled clinical trial with hydroxychloroquine (HCQ) in patients with inflammatory osteoarthritis (OA) of the hands

Charité - University of Medicine, Berlin (Germany)0 个研究点目标入组 510 人开始时间: 2011年6月9日最近更新: 2022年5月30日

适应症

试验速览

•1. Men and women from 40 to 80 years
•2. Presence of clinical hand OA according to American College of Rheumatology (ACR) criteria
•3. Conforming to the ACR criteria for hand OA with recent X ray, dating less than 6 months ago, X ray of the hands showing radiological signs of digital OA in one or more joints as defined by grades 2 or higher, per Kellgren and Lawrence scale or alternatively using the Kallman method or alternativly using the Verbruggen Score;
•4. Symptomatic digital OA with more than three finger joints for more than 3 months (at least every other day) despite taking analgesics and non-steroidal anti-inflammatory drugs (NSAIDs)
•5. Pain above 35 mm as evaluated by the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) -Visual Analogue Scale( VAS) (0 - 100 mm)
•6. Function as co-primary clinical outcome with = 9 using the AUSCAN LK function subscale, or = 225 F (out of maximum of 800) on the AUSCAN VA function subscale

•1. Patients who have already been treated with HCQ
•2. Existence of painful syndrome of upper limbs likely to interfere with the monitoring of pain
•3. Patients suffering or having suffered from secondary OA after one of the following diseases (e.g. infectious arthritis, acromegaly, ochronosis, haemochromatosis, gout, etc.) or inflammatory joint diseases
•4. Any unstable medical condition which would put the patient at an unacceptable risk
•5. Planned Surgery
•6. Local injection with glucocorticoids or other medications within the previous three months
•7. Oral glucocorticoids
•8. Presence of retinopathy

发起方

Charité - University of Medicine, Berlin (Germany)