painful osteoarthritis of the hands MedDRA version: 9.1 Level: LLT Classification code 10016686 Term: Finger osteoarthritis
Conditions
Interventions
Trade Name: PREDNISOLONE 5mg TABLETS
Pharmaceutical Form: Capsule*
INN or Proposed INN: PREDNISOLONE
CAS Number: 50248
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a randomised, double blind, placebo controlled trial to compare the effectiveness of prednisolone versus placebo in a group of patients with painful hand osteoarthritis. Primary outcome is the change in hand pain assessed by Visual Analogue scale at 4 weeks.;Secondary Objective: 1) Change in functional scores (including AUSCAN functional subscale) at 4 and 12 weeks. 2) Change in pain scores (including VAS global disease activity score and AUSCAN pain subscale) at 4 and 12 weeks. 3) Change in OAQoL scores at 12 weeks. 4) Change in HADS scores at 4 and 12 weeks. 5) Changes on eMRI scan at baseline and 4 weeks. MRIs will be scored for synovitis using a semi-quantitative scoring system. ;Primary end point(s): The end points are defined as: • Completion of 12 weeks in the study • Withdrawal due to any reason | — |
Countries
United Kingdom
Outcome results
None listed