A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02740231
• Date of registration: 13/04/2016
• Prospective Registration: No
• Primary sponsor: Bone Therapeutics S.A
• Public title: A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis
• Scientific title: A Two-stage 6-month Multicentre, Randomised, Double-blind, Controlled Study on the Safety and Efficacy Intra-articular Administration of JTA-004 in Patients With Symptomatic Knee Osteoarthritis
• Date of first enrolment: February 2016
• Target sample size: 229
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02740231
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ability to provide a written, dated, and signed informed consent prior to any study
related procedure, and to understand and comply with study requirements

- Ambulatory

- Diagnosed with primary knee osteoarthritis, fulfilling the following American College
of Rheumatology (ACR) criteria at the target knee:

- Pain = 40 mm on a 0-100 mm VAS during the 3 days preceding the date of the
screening visit

- Morning stiffness not exceeding 30 minutes

- Kellgren-Lawrence grade II or III

- Insufficient / failed response to analgesic and / or NSAIDs

- No physical therapy of the knee, and knee braces for the entire duration of study

Exclusion Criteria:

Current symptoms and/or signs related to the disease under study:

- Isolated symptomatic femoropatellar OA of the target knee

- History of trauma or surgery or arthroscopy at the target knee within 6 months before
inclusion

- Concomitant inflammatory disease or other condition affecting the joints (e.g.,
rheumatoid arthritis, septic arthritis, inflammatory joint disease, metabolic bone
disease, psoriasis, gout, microcrystalline arthropathies/chondrocalcinosis, Paget's
disease)

- Any musculoskeletal condition (such as hip osteoarthritis, amputation, neurologic
disorder) that would impede measurement of efficacy at target knee

- Target knee prosthesis planned within 12 months after the Screening Visit

Current or previous diagnoses, signs and/or symptoms:

- Uncontrolled diabetes mellitus, end-stage hepatic or renal disease

- Current (or within the last 5 years prior to entering the study) history of solid or
haematological neoplasia or bone marrow transplantation (except for basal cell
carcinoma and completely excised squamous cell carcinoma)

- Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or
laboratory abnormalities, as judged by the Investigator

- Current or past history of coagulation disorders, as judged by the Investigator

- Hypersensitivity to any components of HA-based injection products

- History of hypersensitivity to human biological material including blood and blood
derived products, potential excipients and residues from manufactoring process
documented clinically or by laboratory tests

- Hypersensitivity to avian proteins

- Life expectancy less than 6 months

Current or previous treatment:

- Participation in another clinical study within 6 months prior to Screening

- Patients previously treated with JTA-004

- Treatment:

- Within 6 months prior to Screening: intra-articular hyaluronic acid injection at
the target knee

- Within 2 months prior to Screening: intra-articular glucocorticoids at the target
knee

- Current chemo-, radio- or immuno-cancer-therapy or immunosuppressive therapy

- Current (or within 6 months prior to Screening) illicit drug abuse

Safety aspects concerning female subjects of childbearing potential:

- Females who are pregnant, lactating or woman with childbearing potential (last
menstrual bleeding less than 12 months ago) unwilling to use medically acceptable
contraception, or women with childbearing potential unwilling to perform a pregnancy
test before administration of study treatment.

Other exclusion criteria:

- Body Mass Index (BMI) of 35 kg/m2 or greater



Age minimum: 50 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Knee Osteoarthritis

Intervention(s)

Device: Reference product intra-articular injection

Drug: JTA-004 intra-articular injection

Primary Outcome(s)

Change from baseline in WOMAC VA3.1 pain subscale score at Month 6 [Time Frame: 6 months]

Secondary Outcome(s)

WOMAC® pain subscale at Month 3 [Time Frame: 3 months]

WOMAC® total score over time [Time Frame: 6 months]

Secondary ID(s)

JTA-KOA1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors