E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
osteoarthritis of the knee |
|
MedDRA Classification |
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 |
To assess whether there is a clinical relevant effect over a period of 12 months of intra-articular injections with high-molecular-weight HA competed to usual treatment in patients with osteoarthritis of the knee in secondary care (The usual care consists of exercise therapy according to the Dutch physiotherapy guidelines and/or pain medication with acetaminophen and/or NSAIDs). |
|
E.2.2 | Secondary objectives of the trial |
To assess whether there is cost-effectiveness over a period of 12 months of additive intra-articular injections with high-molecular-weight HA to usual care treatment in patients with osteoarthritis of the knee in secondary care. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
knee pain needs to be present longer than 3 months, severity of the knee pain needs to be more than 2 mm on a VAS score, and radiographic signs of knee OA needs to be present, defined by a Kellgren & Lawrence score of grade 1 to 3. |
|
E.4 | Principal exclusion criteria |
viscosupplementation in the target knee within the last year, glucocorticoid or steroid injection into the target knee within the last three months, intra-articular procedure (arthroscopy (< 6 months), lavage, tibial osteotomy) within the last year, history of synovectomy, knee surgery scheduled within the next 9 months, dermatologic disorders or skin infection in proximity to the study knee, pregnant or planning to be pregnant or lactating females, poor general health status or specific condition that would interfere with functional assessments (bed ridden patients or patients in wheelchair or who are unable to walk 50 steps unaided), inflammatory arthritis, varus or valgus deformity > 12 degrees, chondrocalcinosis, presence of hip OA severe enough to affect the evaluation of function, receiving regular analgesic therapy for reasons other than painful OA of the knee, chronic use of daily (oral) steroid therapy, alcoholism, patients from whom it is not sure that they will be able to attend the follow-up measurements, insufficient command of the Dutch language, spoken and/or written. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in percentage of responders as defined by OMERACT-OARSI (improvement of minimally 20% in at least 2 of the 3 following domains; pain, function, patient’s global assessment) after 12 months of follow-up. |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |