A Phase 3,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Clinical Performance and Safety of an Intra-articular Solution of High and Low Molecular Weight Hyaluronic Acid (HL-01) in the Treatment of Pain in Symptomatic Knee Osteoarthritis

IBSA Institut Biochimique SA31 sites in 5 countries692 target enrollmentJune 29, 2017

ConditionsKnee Osteoarthritis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: IBSA Institut Biochimique SA
Enrollment: 692
Locations: 31
Primary Endpoint: Change in VAS (Visual Analogue Scale) pain score
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a study to evaluate the Clinical Performance and Safety of a single intra-articular (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to osteoarthritis (OA) of the knee.

Registry

clinicaltrials.gov

Start Date

June 29, 2017

End Date

October 30, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IBSA Institut Biochimique SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female and male subjects ≥40 to 80 years of age.
•Subjects with primary knee OA of the medial or lateral femoro-tibial compartment, documented according to ACR criteria with symptoms, at screening, from at least 3 months.
•Subjects with Kellgren \& Lawrence (K-L) radiological grade 2-
•Subjects with at least one antero-posterior view X-Ray image of the target knee taken within 12 months prior to the screening.
•Subjects with OA pain intensity meeting the criteria below:
•If unilateral knee OA: Subjects demonstrating at screening pain intensity in the target knee measured by Visual Analogue Scale (VAS) ≥40 mm VAS, and ≤ 20 mm in the contralateral knee and confirmed at randomization after wash-out from analgesics/NSAIDs.
•If bilateral knee OA: definition of the most symptomatic joint at screening based on subject's evaluation and Investigator's clinical judgment with subjects demonstrating pain intensity in the target knee measured by Visual Analogue Scale (VAS) ≥40 mm VAS, and ≤ 20mm in the contralateral knee and confirmed at randomization after wash-out from analgesics/NSAIDs.
•Subjects are able to understand and are willing and able to comply with study procedures including usage of acetaminophen as the only analgesic.
•Subjects are able to provide informed consent.
•Any female subject of childbearing potential must agree to use adequate methods of contraception throughout the course of the study.

Exclusion Criteria

•Subjects with secondary (post-traumatic) knee OA of the target and non-target joints.
•Subjects with K-L radiological grade 4 knee OA.
•Subjects with a history of knee joint replacement/arthroplasty of the target knee.
•Subjects with a history of arthroscopy, osteotomy, or surgery of the target knee in the past 12 months.
•Subjects with any significant injury to the target knee in the last 6 months (as per Investigator judgment).
•Subjects with Body Mass Index (BMI) ≥32 kg/m
•Subjects with any musculoskeletal condition affecting the target knee that would impair proper assessment of the Investigational Medicinal Device (IMD) performance in the target knee as assessed by the Investigator and such as:
•severe varus/valgus deformity (\>15°)
•predominantly patello-femoral pain/syndrome.
•Subjects with a history of symptomatic hip OA or other health condition i.e. associated with pain and interfering with adequate study endpoints evaluation.

Outcomes

Primary Outcomes

Change in VAS (Visual Analogue Scale) pain score

Time Frame: Baseline-week 24

The primary efficacy variable will be the change from baseline of the VAS pain score calculated as a VAS measure ranging from 0 to 100 mm. A four- step analysis will be followed in order to assess superiority of HL-01 versus Placebo after 6, 12, 18 and 24 weeks.

Secondary Outcomes

Change in global status assessed by physician(Baseline -Week 24)
Change in global status assessed by subject (EQ-5D-5L EuroQol Group Health questionnaire)(Baseline-Week 24)
Change in Lequesne's Algofunctional Index(Baseline-Week 24)
Rescue medication usage(Week 6-Week 24)
Overall response rate according to OMERACT (Outcome Measures in Rheumatology)-OARSI (Osteoarthritis Research Society International) criteria(Week 6-Week 24)