E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
painful osteoarthritis of the hands |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016686 |
E.1.2 | Term | Finger osteoarthritis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The end points are defined as: • Completion of 12 weeks in the study • Withdrawal due to any reason
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is the last visit of the last subject in the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |