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

NCT02740231 | Completed Phase 2 Results DMC

• 1 other identifier: JTA-KOA1
• Study Type: interventional
• Target: 173
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteoarthritis (OA) is the most common joint disease affecting millions of people around the world, for which there is unfortunately no cure. Among existing therapies, viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an established place in the symptomatic treatment of knee OA. The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in two phases. With results obtained in the first phase the best dose of JTA-004 is determined, and the efficacy of the selected dose will then be confirmed in the second phase.

Conditions

Knee Osteoarthritis

Keywords

viscosupplement; osteoarthritis; knee; intra-articular injection; arthritis; degenerative

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6

  The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group. Results are expressed as "adjusted mean" based on the model used for group comparison. WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.

  Baseline and 6 months

Secondary Outcomes (4)

• WOMAC® Pain Subscale at Month 3

  Baseline and 3 months

• WOMAC® Total Score Over Time

  Baseline and 2 weeks

• WOMAC® Total Score Over Time

  Baseline and 3 months

• WOMAC® Total Score Over Time

  Baseline and 6 months

Study Arms (4)

Reference product

ACTIVE COMPARATOR

Hylan G-F 20

Device: Reference product intra-articular injection

JTA-004 50 (2 ml)

EXPERIMENTAL

Sodium hyaluronate, plasma proteins and clonidine

Drug: JTA-004 intra-articular injection

JTA-004 50 (4 ml)

EXPERIMENTAL

Sodium hyaluronate, plasma proteins and clonidine

Drug: JTA-004 intra-articular injection

JTA-004 100 (2 ml)

EXPERIMENTAL

Sodium hyaluronate, plasma proteins and clonidine

Drug: JTA-004 intra-articular injection

Interventions

JTA-004 intra-articular injection DRUG

Each patient will undergo a single injection of JTA-004 into the knee joint

JTA-004 100 (2 ml); JTA-004 50 (2 ml); JTA-004 50 (4 ml)

Reference product intra-articular injection DEVICE

Each patient will undergo a single injection of Reference product into the knee joint

Reference product

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current symptoms and/or signs related to the disease under study:
• Isolated symptomatic femoropatellar OA of the target knee
• 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 manufacturing process documented clinically or by laboratory tests
• Hypersensitivity to avian proteins
• Life expectancy less than 6 months
• Current or previous treatment:

Sponsors & Collaborators

• Bone Therapeutics S.A: lead

Related Publications (1)

• Bettonville M, Leon M, Margaux J, Urbin-Choffray D, Theunissen E, Besse-Hammer T, Fortems Y, Verlinden S, Godeaux O, Delmarcelle AS, Kaux JF. Safety and efficacy of a single intra-articular injection of a novel enhanced protein solution (JTA-004) compared to hylan G-F 20 in symptomatic knee osteoarthritis: a randomized, double-blind, controlled phase II/III study. BMC Musculoskelet Disord. 2021 Oct 19;22(1):888. doi: 10.1186/s12891-021-04750-3.

  PMID: 34666767 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr Olivier Godeaux Medical Officer
• Organization: Bone Therapeutics

jta.koa1@bonetherapeutics.com

+32 71 12 10 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 15, 2016
• Study Start: February 1, 2016
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-10