Patients with symptomatic osteoarthritis of the knee. MedDRA version: 9.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis
Conditions
Interventions
Trade Name: HYALGAN
Pharmaceutical Form: Solution for injection
Sponsors
Rottapharm SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who fulfilled the following criteria are eligible: • patients who signed the informed consent to participate in the study, • female/male, age from 50 to 80 year inclusive, • patients with femorotibial OA of the knee. The diagnosis of knee osteoarthritis will be based on the clinical and radiographic classification criteria developed by the American College of Rheumatology (ACR) (Altman R. et al., 1986), i.e.: - Knee pain, - X-ray osteophytes and - at least one of 3: age >50 years and/or morning stiffness =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The main exclusion criteria are the following: • isolated or predominantly symptomatic femoropatellar OA of the knee, • evidence of secondary osteoarthritis, • rheumatic diseases other than osteoarthritis, • with “clinical joint effusion” of the target knee on the day of screening, • history of allergy or known hypersensitivity to hyaluronic acid and/or hypersensitivity to any of the components of the products under study, • patients in which both rescue medications (paracetamol/NSAID) are contraindicated, • any significant health problem, • known hepatic function abnormalities, • skin infection or disease at the injection site, • use of any experimental drug within the previous 3 months, • obese patients (BMI =32), • patients who have been treated with: - intra-articular steroid during the previous month or systemic steroid drugs within the 3 months preceding randomization and/or - intra-articular hyaluronic acid in the target knee during the previous 12 months, • ongoing anticoagulant treatment (except patients on low dose aspirin, not exceeding 325 mg per day), • patients with symptomatic hip OA homolateral to the target knee, • pregnant or lactating women, and women of childbearing potential (using adequate contraceptive method for at least 1 year) not willing to keep on using adequate contraceptive method for the duration of the study, • perceived inability/unwillingness to fully comply with all protocol requirements. • Patients who underwent extensive surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) and/or uncomplicated meniscectomy if performed within the last 12 months before the screening visit of the target knee. [Even if meniscectomy is a RISK FACTOR for knee OA, it is not considered an exclusion criteria if performed > 12 months before the screening visit]. • Patients who have received any investigational drug/device within 3 months prior to the screening visit and/or patients who are scheduled to take part in other clinical trial during the course of this trial. • Patients with a severe concomitant disease at any organ or apparatus (including acute or chronic infective diseases) that may interfere with the free use and evaluation of the affected knee for the 6 months course of the trial and/or current treatment or treatment within the previous 2 years prior to the screening visit for any malignancy (excluding basal cell or squamous cell carcinoma of the skin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of GO-ON in comparison to Hyalgan on knee pain in patients with symptomatic Knee OA at 26 weeks.;Secondary Objective: • to compare the efficacy of GO-ON and Hyalgan on secondary efficacy parameters. • to identify Responder patients to the OMERACT-OARSI, MCII and PASS criteria. • to evaluate the safety of the studied products in patients with symptomatic knee OA. ;Primary end point(s): The primary objective of the statistical analysis will be the assessment of non-inferiority of GO-ON with respect to Hyalgan in the control of knee pain, 26 weeks after the first injection. Mean variation of the mean WOMAC pain (rated on a 0 – 100 mm Visual Analogue Scale), calculated on the PP population, will be used as primary efficacy parameter. GO-ON will be declared non-inferior to Hyalgan, rejecting the Null Hypothesis, if the lower limit of the 95% Confidence Interval of the difference will lie above the lower equivalence (non-inferiority) margin (-9 mm). | — |
Countries
Germany
Outcome results
None listed