Osteo Arthritis Knee
Conditions
Keywords
Hyaluronic Acid, Chondroitin sulfate
Brief summary
This is a multicentre, prospective, sponsor initiated clinical investigation that aims to evaluate safety and efficacy of Hyaluronic Acid Combined With Chondroitin Sulfate in symptomatic patients with OA of the knee.
Interventions
DEVICEHyaluronic Acid Combined With Chondroitin Sulfate
Subjects' participation in the study will last 26 weeks. The study includes 7 visits that consist of a Screening visit, three treatment visits and three follow-up visits. Eligible subjects will undergo a Baseline visit (V1 at week 0) during which, after the confirmation of eligibility, assessments and ultrasound evaluation, the study subjects will be treated with the 1st injection of 2%Hyaluronic Acid and 2% chondroitin sulfate Subsequent treatments will be administered at weekly intervals during Visit 2 (V2 at week 1) and Visit 3 (Visit 3 at week 2) after the effectiveness assessments. Study subjects will return for Follow-up visits 1 month (Visit 4 at week 6), 3 months (Visit 5 at week 14) and 6 months (Visit 6 at week 26) after the last injection
Sponsors
Fidia Farmaceutici s.p.a.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* At Screening * Male or female between the ages of 40 and 80 * Body Mass Index (BMI) ≤ 30; * Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40. The most painful knee is considered the target knee; * OA of the Knee radiologically and clinically confirmed responding to criteria of American College of Rheumatology (ACR): pain of the knee and crepitus on active motion or morning stiffness less than 30 minutes or age \>50 years * Symptomatic knee pain for more than 6 months; * Radiological Kellgren and Lawrence grade II or III confirmed by an X-ray not older than 12 months; * Willing to discontinue any systemic analgesic/NSAID therapy, opioids, systemic corticosteroids, skeletal muscle relaxants, and any other medication that would interfere with the study assessments, except for the rescue medication, with no intention to resume them during the clinical investigation (see Appendix 5 for wash out period); * Patient able to comply with the instructions of the clinical investigation and to maintain a Rescue Medication Diary during the study; * Having signed the study informed consent. * at Baseline * Patient does not have chondromatosis or villonodular synovitis of the knee evaluated by Ultrasound; * Patient has complied with the requirements for rescue medication (no more than 6 tablets or 3 grams of paracetamol per day up to 4 days per week and paracetamol discontinued 24 hours before first IA injection); * Mean knee pain score at rest over the last 24 hours evaluated on VAS (0 - 100) ≥ 40 (with a washout period for Paracetamol of 24 hours); * Patient has discontinued prior to Baseline the use of all prohibited medications in accordance with the washout period defined in Appendix 5; * Patient continues to meet all Screening inclusion/
Exclusion criteria
at the Baseline visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score measured by Visual Analogue Scale (VAS) | at week 6, 14 and 26 | Change in pain perception from baseline in patient with knee osteoarthritis after three intra-articular 2% Chondroitin Sulfate + 2% hyaluronic Acid injections assessed by Visual Analogue Scale (VAS) (From 0 to 100) at weeks 6, 14 and 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in knee pain and function up to 26 weeks | at weeks 6, 14 and 26 | Change from baseline provided by the intra-articular 2% Chondroitin Sulfate + 2% Hyaluronic Acid injections measured by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index (0-100 mm) for knee at weeks 6, 14 and 26 |
| Change from baseline up to 26 weeks after first treatment on knee functional disability on Clinical Observer Global Assessment (COGA) | at weeks 6, 14 and 26 | Change from baseline up to 26 weeks after first treatment in COGA of knee functional disability, assessed by VAS (0-100) |
| Number of patients Responder to treatment | Weeks 6, 14 and 26 | Number of patients with clinical response to treatment using the OMERACT-OARSI set of criteria: high improvement in pain or function ≥ 50% or improvement in at least 2 of the 3 of the following criteria: high improvement in pain or function ≥ 50% or improvement in at least 2 of the 3 following: * pain ≥ 20% and absolute change ≥10, * function ≥20% and absolute change ≥10, * PGA ≥ 20% and absolute change ≥10. |
| Change from baseline in Synovitis at 6 weeks | at week 6 | Change in Synovitis at week 6 vs week 0 assessed by ultrasound scored according to the scoring systems proposed by OMERACT US on knee OA. A global score for synovitis corresponds to the maximum score for synovitis obtained at the suprapatellar or parapatellar recesses. Synovitis (grades 0-3): Grade 0 = no synovitis, Grade 1= minimal distension, Grade 2= moderate distension or enlargement, Grade 3= severe distension or enlargement of the recess |
| Change in Patient's Global Assessment | at weeks 6, 14 and 26 | Change from baseline up to 26 weeks after first treatment in Patient's Global Assessment of knee functional disability, assessed by VAS (0-100) |
| Change from baseline in knee Effusion at 6 weeks | at week 6 | Change in Effusion at week 6 vs week 0 assessed by ultrasound scored according to the scoring systems proposed by OMERACT US on knee OA. Effusion (0-1) 0= absence, 1= presence |
| Change from baseline in popliteal cyst at 6 weeks | at week 6 | Change in Popliteal cyst at week 6 vs week 0 assessed by ultrasound scored according to the scoring systems proposed by OMERACT US on knee OA. Popliteal cyst (0-1) 0= absence, 1= presence |
| Change in Synovial Power Doppler signal at week 6 | at week 6 | Changein Synovial Power Doppler signal at week 6 vs week 0 assessed by ultrasound. Synovial Power Doppler signal (0-1) and (0-3) Grade 0 = no intra-articular colour signal Grade 1 = up to three signal colour signals or two single and one confluent colour signals representing only low flow |
| Safety of the treatment. Number of patient with treatment related adverse events | through study completion | Safety evaluation by tracking the number of patient withdrawals and their adverse events correlated to treatment at each visit |
| Change from baseline in Synovial hypertrophy at 6 weeks | at week 6 | Change in Synovial hypertrophy at week 6 vs week 0 assessed by ultrasound scored according to the scoring systems proposed by OMERACT US on knee OA. Synovial hypertrophy (0-1) where 0= absence, 1= presence |
Countries
Czechia
Outcome results
None listed