Treating painful hand osteoarthritis using low dose oral prednisolone- assessing short-term pain and imaging outcomes - POLO

Conditions: painful osteoarthritis of the hands
MedDRA version: 9.1Level: LLTClassification code 10016686Term: Finger osteoarthritis

Registration Number: EUCTR2009-011173-32-GB

Lead Sponsor: niversity of Leeds

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Patients must fulfil the American College of Rheumatology criteria for OA of the small joints of the hand (see appendix B).
2.Moderately severe symptoms (=40/100 on hand pain 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 NSAIDs) for at least 4 weeks.
6.Stable doses of chondroitin or glucosamine for 4 months.
7.No oral, IM, IA, or 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 MRI scanning:

•Pacemakers
•Surgical clips within the head
•Certain inner ear implants
•Neuro-electrical stimulators
•Metal fragments within the eye or head
•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