Back to results

Long-term Safety and Performance of KiOmedine CM-Chitosan Supplementation in Advanced Symptomatic Knee Osteoarthritis (PIONEER)

Primary Purpose

Osteoarthritis, Knee

Status

Active

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

KiOmedine® CM-Chitosan

Synvisc-One®

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged ≥ 40 years and ≤ 85 years.
Advanced osteoarthritis, involving one or multiple of the following phenotypes: tricompartmental osteoarthritis, isolated or severe patella-femoral osteoarthritis, a BMI ≥ 30 kg/m2, and/or a Kellgren and Lawrence grade III or IV classification:
- Patellofemoral osteoarthritis referring to symptoms, including pain, that are principally of patellofemoral origin (Patellar syndrome).
- Radiological Kellgren and Lawrence grade III to IV from a standing knee radiograph taken less than 6 months previously.
Symptomatic osteoarthritis diagnosed via radiographic assessment and according to the clinical and radiological criteria of the American College of Rheumatology (ACR).
Single intra-articular corticosteroid injection during the screening visit (V0), according to standard clinical practice, to resolve clinically apparent knee effusion and/or local signs of inflammation. Patients can only participate in the clinical investigation when there is no sign of effusion and no local signs of inflammation at the patient in visit (V1) which is planned 1-2 weeks after the screening visit.
Moderate to severe symptomatic pain (i.e., total score on the WOMAC pain subscale ≥12) at screening visit in the treatment knee not or poorly responding to first line non-opioid analgesics and non-steroidal anti-inflammatory drug in oral uptake.
Pain criteria assessed prior to injection using the 5-point Likert WOMAC pain score:
- Treatment knee: moderate to severe pain in the most affected knee (i.e., total score on the WOMAC pain subscale ≥12).
- Non-treatment knee: no to mild pain in the less/non affected knee (i.e., total score on the WOMAC pain subscale ≤5).
Fully ambulatory patient for functional evaluation.
For female NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least one year, must have an effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device).
Able to understand and follow the instructions of the study.
Having signed a written informed consent.

Exclusion Criteria:

Meeting one of the following contraindications as stated in the instructions for use of KiOmedine® CM-Chitosan or Synvisc® One:

A known allergy or hypersensitivity to any of the product components,
Infections or skin disease at or around the injection site,
Severe inflammation, synovitis or inflammatory arthritis of the knee joint,
A history of autoimmune and crystal diseases,
Evidence of lymphatic or venous stasis or serious blood disorders.

Sites / Locations

Hip and Knee Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group receiving Synvisc-One®

IMD group receiving KiOmedine® CM-Chitosan

Arm Description

Outcomes

Primary Outcome Measures

Percentage change from baseline in knee pain at 6 months post-injection measured by the 5-point Likert WOMAC pain scale.

Secondary Outcome Measures

Percentage change from baseline in knee pain measured by the 5-point Likert WOMAC pain scale.

Percentage change from baseline in knee stiffness measured by the 5-point Likert WOMAC stiffness scale.

Percentage change from baseline in physical functioning measured by the 5-point Likert WOMAC physical functioning scale.

Percentage change from baseline in the total WOMAC score.

Percentage change from baseline in patient's pain and global assessment using an 11-point numerical rating scale.

Response to treatment according to the Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT).

Treatment responders with >40% improvement from baseline in pain measured by the 5-point Likert WOMAC pain scale.

Full Information

NCT ID

NCT05214807

First Posted

January 17, 2022

Last Updated

March 7, 2023

Sponsor

Kiomed Pharma

1. Study Identification

Unique Protocol Identification Number

NCT05214807

Brief Title

Long-term Safety and Performance of KiOmedine CM-Chitosan Supplementation in Advanced Symptomatic Knee Osteoarthritis

Acronym

PIONEER

Official Title

Safety and Performance of an Intra-articular Injection of KiOmedine CM-Chitosan in Patients With Advanced Symptomatic Knee Osteoarthritis: Single-blind Randomized Controlled Trial With a 12-month Follow-up Period.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 26, 2022 (Actual)

Primary Completion Date

August 20, 2023 (Anticipated)

Study Completion Date

February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kiomed Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A single-blind randomized controlled design intended for the assessment of safety and performance of a single intra-articular injection of the IMD. In the study, 92 patients meeting eligibility criteria will be randomly assigned to two groups respectively of 46 subjects receiving a single injection of the IMD and 46 subjects receiving a single injection of Synvisc-One® (Hylan G-F 20) which is selected as comparator. Each patient will be blinded for the treatment he/she receives at the injection visit (single blinding). The patients will be followed for 12 months post-injection to understand long-term safety and performance effects. The study aims to evaluate the safety and performance of a single injection of KiOmedine® CM-Chitosan compared to the comparator device (Synvisc-One®) in patients with advanced symptomatic knee osteoarthritis. The non-inferiority hypothesis for the primary performance objective is that the percentage mean reduction in pain from baseline at 6 months in the KiOmedine® CM-Chitosan group is non-inferior to that of the comparator group considering a non-inferiority margin. If the hypothesis of non-inferiority is met, then superiority testing will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group receiving Synvisc-One®

Arm Type

Active Comparator

Arm Title

IMD group receiving KiOmedine® CM-Chitosan

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

KiOmedine® CM-Chitosan

Intervention Description

KiOmedine® CM-Chitosan is a fluid implant intended for synovial fluid supplementation for the symptomatic treatment of osteoarthritis (OA). This Investigational Medical Device (IMD) is administered via intra-articular injection and is classified as a Class III Device under Council Directive 93/42/EEC (Annex IX, rule 8). A key component of the IMD is a soluble derivative of highly purified chitosan of non-animal origin, an exclusive natural linear glucosamine polysaccharide extracted from the edible white mushroom, Agaricus bisporus. KiOmedine® CM-Chitosan is sterile, non-pyrogenic, resorbable and composed of 2% (w:w) carboxymethyl chitosan (CM-chitosan).

Intervention Type

Device

Intervention Name(s)

Synvisc-One®

Intervention Description

Synvisc-One (Hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing Hylan A and Hylan B polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan A has an average molecular weight of approximately 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F 20 contains Hylan A and Hylan B (8.0 mg ± 2.0 mg per ml) in buffered physiological sodium chloride solution (pH 7.2 ± 0.3) and is unique in that the hyaluronan is chemically crosslinked.

Primary Outcome Measure Information:

Title

Percentage change from baseline in knee pain at 6 months post-injection measured by the 5-point Likert WOMAC pain scale.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Percentage change from baseline in knee pain measured by the 5-point Likert WOMAC pain scale.

Time Frame

2 weeks, 3 months, 9 months and 12 months post-injection.

Title

Percentage change from baseline in knee stiffness measured by the 5-point Likert WOMAC stiffness scale.

Time Frame

2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.

Title

Percentage change from baseline in physical functioning measured by the 5-point Likert WOMAC physical functioning scale.

Time Frame

2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.

Title

Percentage change from baseline in the total WOMAC score.

Time Frame

2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.

Title

Percentage change from baseline in patient's pain and global assessment using an 11-point numerical rating scale.

Time Frame

2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.

Title

Time Frame

2 weeks, 3 months, 6 months, 9 months and 12 months post-injection.

Title

Treatment responders with >40% improvement from baseline in pain measured by the 5-point Likert WOMAC pain scale.

Time Frame

2 weeks, 3 months, 6 months, 9 months, and 12 months post-injection.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged ≥ 40 years and ≤ 85 years. Advanced osteoarthritis, involving one or multiple of the following phenotypes: tricompartmental osteoarthritis, isolated or severe patella-femoral osteoarthritis, a BMI ≥ 30 kg/m2, and/or a Kellgren and Lawrence grade III or IV classification: Patellofemoral osteoarthritis referring to symptoms, including pain, that are principally of patellofemoral origin (Patellar syndrome). Radiological Kellgren and Lawrence grade III to IV from a standing knee radiograph taken less than 6 months previously. Symptomatic osteoarthritis diagnosed via radiographic assessment and according to the clinical and radiological criteria of the American College of Rheumatology (ACR). Single intra-articular corticosteroid injection during the screening visit (V0), according to standard clinical practice, to resolve clinically apparent knee effusion and/or local signs of inflammation. Patients can only participate in the clinical investigation when there is no sign of effusion and no local signs of inflammation at the patient in visit (V1) which is planned 1-2 weeks after the screening visit. Moderate to severe symptomatic pain (i.e., total score on the WOMAC pain subscale ≥12) at screening visit in the treatment knee not or poorly responding to first line non-opioid analgesics and non-steroidal anti-inflammatory drug in oral uptake. Pain criteria assessed prior to injection using the 5-point Likert WOMAC pain score: Treatment knee: moderate to severe pain in the most affected knee (i.e., total score on the WOMAC pain subscale ≥12). Non-treatment knee: no to mild pain in the less/non affected knee (i.e., total score on the WOMAC pain subscale ≤5). Fully ambulatory patient for functional evaluation. For female NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least one year, must have an effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device). Able to understand and follow the instructions of the study. Having signed a written informed consent. Exclusion Criteria: Meeting one of the following contraindications as stated in the instructions for use of KiOmedine® CM-Chitosan or Synvisc® One: A known allergy or hypersensitivity to any of the product components, Infections or skin disease at or around the injection site, Severe inflammation, synovitis or inflammatory arthritis of the knee joint, A history of autoimmune and crystal diseases, Evidence of lymphatic or venous stasis or serious blood disorders.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathias Schifflers, MD

Organizational Affiliation

Kiomed Pharma

Official's Role

Study Director

Facility Information:

Facility Name

Hip and Knee Unit

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Long-term Safety and Performance of KiOmedine CM-Chitosan Supplementation in Advanced Symptomatic Knee Osteoarthritis

We'll reach out to this number within 24 hrs