| Eligibility |
Inclusion Criteria:
- Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one)
is allowed if already used at screening but should be avoided during the study up to
the 6-month follow-up visit)
- Diagnosed with primary knee OA, fulfilling the following American College of
Rheumatology (ACR) criteria at the target knee:
- Pain present for most days of the preceding month
- Morning stiffness < 30 minutes
- Kellgren-Lawrence grade II or III (confirmed by appropriate X-rays taken within 6
months prior to screening visit)
- Target knee pain = 200 mm and = 400 mm out of 500 mm on the WOMAC® VA3.1 pain
questionnaire (sum of 5 questions) at screening and baseline
- Insufficient/failed response or intolerance to analgesics and/or non-steroidal
anti-inflammatory drugs (NSAIDs) as reported by the subject
- Willing and able to abstain from initiation of physical therapy and of use of knee
braces at the target knee up to the 6-month follow-up visit (a subject undergoing
physical therapy or using knee braces at a stable frequency for at least 2 weeks prior
to screening is allowed to continue at same frequency (frequency increase is not
allowed))
- Capable to understand and comply with study requirements and to provide a written,
dated, and signed informed consent prior to any study procedure for participation in
the study and transmission of personal "pseudo-anonymized" data
Exclusion Criteria:
1. History of trauma or surgery or arthroscopy at the target knee within 12 months before
inclusion
2. Concomitant inflammatory disease or other conditions affecting the joints (e.g.,
infectious arthritis, rheumatoid arthritis, psoriatic arthritis or
spondyloarthropathy, Paget's disease, hemochromatosis…)
3. Any target knee abnormality that could impact safety or efficacy assessment
4. Microcrystalline arthropathies: chondrocalcinosis/calcium pyrophosphate dihydrate
disease (pseudo-gout) or gout if believed likely to interfere with the study
endpoints, in the opinion of the Investigator
5. Clinically significant valgus/varus deformities at the Investigator's discretion
6. Any musculoskeletal condition (such as symptomatic hip OA, amputation, neurologic
disorder, chronic back pain with or without radiculopathy, sciatica) that would impede
measurement of efficacy at target knee
7. Contralateral knee pain equal to or exceeding the pain in the target knee (on the
WOMAC® VA3.1 pain questionnaire) at screening and/or baseline
8. Knee arthroplasty planned within 12 months after the screening visit Current or
previous diagnoses, signs and/or symptoms
9. Uncontrolled diabetes mellitus (hemoglobin A1c [HbA1c] > 10% or > 86 mmol/mol),
end-stage hepatic or renal disease (severe and clinically significant abnormalities
according to local laboratory ranges) documented in the subject's file
10. Any relevant cardiovascular disease (severe coronary insufficiency, conduction
disturbances, recent myocardial infarction, cerebrovascular disease) or any clinically
significant electrocardiogram (ECG) abnormality as judged by the Investigator
11. Subject with neuropathic pain or chronic pain syndrome including fibromyalgia
12. Current (or within the last 5 years prior to entering the study) history of solid or
hematological neoplasia or bone marrow transplantation (except for basal cell
carcinoma and completely excised squamous cell carcinoma)
13. Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or
laboratory abnormalities, as judged by the Investigator
14. Current or past history of coagulation disorders (according to local laboratory
ranges), as judged by the Investigator
15. Hypersensitivity to any components of hyaluronic acid (HA)-based injection products
16. Hypersensitivity to human biological material including blood and blood-derived
products, potential excipients and residues from manufacturing process, documented
clinically or by laboratory tests
17. Hypersensitivity to avian proteins Current or previous treatment
18. Participation in another clinical trial within 3 months prior to screening (within 1
year prior to screening if disease-modifying OA drug (DMOAD) received and if the
Investigator considers it could impact the safety or efficacy assessment)
19. Subject previously treated with JTA-004 within 2 years prior to screening
20. Subject treated with intra-articular viscosupplement or blood-derived product (e.g.,
platelet-rich plasma) injection in the target knee within 6 months prior to screening
21. Subject treated with intra-articular glucocorticoid injection in the target knee
within 4 months prior to screening
22. Subject having started the use of slow acting drugs for OA such as glucosamine,
glucosamine sulfate, chondroitin sulfate, diacerein, curcumin, soybean/avocado
extracts or related products within 1 month prior to screening
23. Current chemo-, radio- or immuno-cancer-therapy or immunosuppressive therapy
24. Chronic (= 3 days/week within the last 3 months) use of opioids other than weak
opioids (such as codeine, dihydrocodeine, tramadol…)
25. Chronic (> 15 consecutive days) use of systemic steroids Safety aspects concerning
female subjects of childbearing potential
26. Breast-feeding
27. Pregnancy
28. Woman with positive pregnancy test
29. Woman not willing or not able to use a highly effective contraceptive method during
the 6-month active follow-up period. Highly effective birth control methods are:
1. Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal, transdermal)
2. Progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, implantable)
3. Intrauterine device
4. Intrauterine hormone-releasing system
5. Bilateral tubal occlusion Other exclusion criteria
30. Body Mass Index (BMI) of 40 kg/m2 or greater at baseline
31. Signs of an active drug or alcohol dependence, serious current illness, mental illness
or any other factors which may interfere with subject's ability to understand and
comply with study requirements, as judged by the Investigator
32. Life expectancy less than 12 months at screenin
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