Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT04814368
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening
* KOOS pain subscale \<60 for the target knee during Screening
* High sensitivity C-reactive Protein (hsCRP) ≥1.8 mg/L
* Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee
* Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13)
Exclusion Criteria:
* History of, or planned; knee replacement (partial or total) in either knee; arthroscopy or lavage in either knee within 6 months prior to screening; any other previous surgical intervention in the target knee, or for the contralateral knee within 12 months prior to Screening, including mosaicplasty, microfracture, meniscectomy \>50% or osteotomy
* Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening
* Malalignment \>7.5° in the target knee (either varus or valgus)
* Any diagnosis of systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA (e.g. fibromyalgia)
* Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04814368
Study Brief:
Protocol Section:
NCT04814368