Treating painful hand osteoarthritis using low dose oral prednisolone: assessing short-term pain and imaging outcomes in a randomised, placebo-controlled, double-blind, 12 week, single centre study

niversity of Leeds (UK)0 个研究点目标入组 70 人开始时间: 2011年5月9日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Patients must fulfil the American College of Rheumatology criteria for OA of the small joints of the hand
•2. Moderately severe symptoms (greater than or equal to 40/100 on hand pain visual analogue scale [VAS] at screening)
•3. Symptoms present on most days over the last 3 months
•4. A previous radiograph of the hands with changes consistent with osteoarthritis
•5. Stable analgesic requirements (including non-steriodal anti-inflammatory drugs [NSAIDs]) for at least 4 weeks
•6. Stable doses of chondroitin or glucosamine for 4 months
•7. No oral, intramuscular [IM], intra-arterial [IA], or intravenous [IV] steroids during the last 3 months
•8. The patient must be able to adhere to the study visit schedule and other protocol requirements
•9. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
•10. Aged 43 - 81 years, either sex

•1. The presence of an inflammatory arthritis
•2. Sensitivity, anaphylaxis or allergy to prednisolone
•3. Patients who are pregnant, lactating or using hormonal birth control pills
•4. Currently uncontrolled diabetes
•5. Currently uncontrolled hypertension
•6. Current active infection
•7. Surgical procedure within 30 days of study initiation
•8. Patients with osteoporosis or taking bisphosphonates
•9. Patients will not be eligible if they have any contraindications to magnetic resonance imaging (MRI) scanning:
•9.1. Pacemakers
•9.2. Surgical clips within the head
•9.3. Certain inner ear implants
•9.4. Neuro-electrical stimulators
•9.5. Metal fragments within the eye or head
•9.6. Pregnant or breastfeeding women
•10. Use of any investigational (unlicensed) drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer
•11. Subjects with any uncontrolled, unstable or severe medical condition, which in the opinion of the investigator makes them unsuitable for the study

发起方

niversity of Leeds (UK)