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A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200288
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: HL-01: high and low molecular weight hyaluronic acid Device: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 691 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: During the course of the study only the physicians who will perform the intra-articular injection (injectors) will be unblinded. All the other physicians (assessors) and study participants will be blinded
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 29, 2017
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: HL-01
Single 2 ml intra-articular injection of HL-01 (solution of high and low molecular weight hyaluronic acid (HA))
Device: HL-01: high and low molecular weight hyaluronic acid
2 ml intra-articular single injection
Other Name: Sinovial HL®

Placebo Comparator: Placebo
Single 2 ml intra-articular injection of Placebo (physiological solution)
Device: Placebo
2 ml intra-articular single injection




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Lequesne's Algofunctional Index [ Time Frame: Baseline-Week 24 ]
    Change from baseline in Lequesne's Algofunctional Index at 6, 12, 18 and 24 weeks.

  2. Change in global status assessed by subject (EQ-5D-5L EuroQol Group Health questionnaire) [ Time Frame: Baseline-Week 24 ]
    Change from baseline in global status assessed by subject at 6, 12, 18 and 24 weeks (EQ-5D-5L)

  3. Change in global status assessed by physician [ Time Frame: Baseline -Week 24 ]
    Change from baseline in global status assessed by physician at 6, 12, 18 and 24 weeks (5-point verbal Likert scale), dichotomised to 'Improvement' and 'No change/Worsening'

  4. Overall response rate according to OMERACT (Outcome Measures in Rheumatology)-OARSI (Osteoarthritis Research Society International) criteria [ Time Frame: Week 6-Week 24 ]
    Overall response rate according to OMERACT-OARSI criteria at 6, 12, 18 and 24 weeks (this is a statistical analysis)

  5. Rescue medication usage [ Time Frame: Week 6-Week 24 ]
    Rescue medication usage assessed at 6, 12, 18 and 24 weeks.


Other Outcome Measures:
  1. Adverse Events [ Time Frame: Screening -Week 24 ]
    Incidence and frequency of AEs (adverse events)

  2. Level of treatment satisfaction [ Time Frame: Baseline-Week 6 ]
    Level of treatment satisfaction - assessed by subject at baseline (within 15 minutes after the i. a. injection), in 24 hours (+/- 1 hour) after the injection, at week 1 and week 6



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 2-3.
  • 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/m2.
  • 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:

    1. severe varus/valgus deformity (>15°)
    2. 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.
  • Subjects with a known history or present evidence of conditions which may affect the target knee assessments, like rheumatic disease and inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropathies; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations.
  • Subjects with venous or lymphatic stasis in the relevant limb.
  • Subjects with a history of the following treatments for knee OA:

    a) I. a. knee corticosteroids: i. target knee - in the past 3 months ii. non-target knee/other joints - in the past 4 weeks b) Systemic (both oral and parenteral) and topical corticosteroids at the target knee in the past 3 months.

    c) Topical anti-inflammatories and analgesics applied at the target knee in the past 48 hrs.

    d) Viscosupplementation with hyaluronic acid or joint-lavage in the target knee in the past year.

    e) Physical therapy started in the last 3 months in the target knee. f) Symptomatic Slow-Acting Drugs for OA (SYSADOA) such as glucosamine, chondroitin sulfate, diacerhein, or other medications like avocado/soya extracts, etc. in the past 3 months.

    g) Chronic or recurrent use of narcotic analgesics. h) Use of analgesic (other than acetaminophen) and NSAIDs for a time of 5-half-lives before the screening.

  • Subjects with a history of chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee.
  • Subjects treated with drugs having an influence on pain: hypnotics, muscle relaxants, anxiolytics if the intake has started less than 8 days before the screening.
  • Subjects who currently use heparin or anti-vitamin K (e. g. crystalline warfarin) anticoagulant therapy.
  • Subjects with the presence of infection, skin diseases, other disease or trauma in the area of the injection site or joint.
  • Subjects with a known history or suspected allergy or hypersensitivity to hyaluronic acid or to hyaluronate preparations.
  • Subjects with a known history or suspected allergy or hypersensitivity to acetaminophen.
  • Subjects with any major surgery scheduled in the next 6 months.
  • Subjects who have participated in a clinical study / investigation in the last 3 months.
  • Pregnant or lactating women and women of childbearing potential not willing to use adequate contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200288


Locations
Show Show 31 study locations
Sponsors and Collaborators
IBSA Institut Biochimique SA
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Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT03200288    
Other Study ID Numbers: 16EU-Hai13
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents