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    Summary
    EudraCT Number:2021-000180-70
    Sponsor's Protocol Code Number:2020-09(04)
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-02-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedIreland - HPRA
    A.2EudraCT number2021-000180-70
    A.3Full title of the trial
    Knee osteoarthritis Injection Therapy (KNiT) trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial comparing three commercially available injection therapies for treatment of knee osteoarthritis
    A.3.2Name or abbreviated title of the trial where available
    KNiT
    A.4.1Sponsor's protocol code number2020-09(04)
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBeacon Hospital
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBeacon Hospital
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeacon Hospital
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressBeacon Court, Bracken Rd, Sandyford
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code D18 AK68
    B.5.3.4CountryIreland
    B.5.4Telephone number35312937575
    B.5.5Fax number35312938607
    B.5.6E-mailjoseph.queally@beaconhospital.ie
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Depo-Medrone
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Healthcare Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDepo-Medrone
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPREDNISOLONE
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE ACETATE
    D.3.9.4EV Substance CodeSUB03255MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Marcain Polyamp
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMarcain Polyamp
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbupivacaine
    D.3.9.1CAS number 18010-40-7
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE, ANHYDROUS
    D.3.9.4EV Substance CodeSUB71293
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Knee osteoarthritis (OA). Osteoarthritis (OA) is a debilitating disease which mostly affects people over 60 years of age. It is known to be within the top 10 contributors to years lived with disability worldwide1. The increasing number of patients with symptomatic OA in an ageing population will continue to place an increasingly larger economic burden on global healthcare systems. The knee is a common location for the disease, causing pain, stiffness and problems with sleep and daily activities.
    E.1.1.1Medical condition in easily understood language
    Wear and tear of the knee joint
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the KNiT trial is to evaluate and compare the effectiveness of three injection treatments as a treatment to reduce symptoms in knee osteoarthritis:
    1. corticosteroid (CS)
    2. platelet-rich plasma (PRP)
    3. PRP+hyaluronic acid (PRP+HA)

    The primary objective of the KNiT trial is to evaluate the effectiveness of the injection treatments to reduce patient reported symptoms, including pain and disability caused by the knee osteoarthritis. This will be assessed using a knee-specific patient reported outcome measure (PROM), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee score.
    E.2.2Secondary objectives of the trial
    The secondary objective of the KNiT trial is to evaluate the injection treatments can specifically reduce pain, improve quality-of-life and delay the need for surgical treatment (e.g., knee joint replacement). This will be assessed using the EuroQol EQ-5D-5L health related quality-of-life score, and by reporting reasons for drop-out during the study period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion, each subject must meet each of the following criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2):
    - Age over 30 years
    - Mean VAS pain score of >40 of 100 (worst possible pain) over the course of 7 days during the previous month
    - OA diagnosed by the American College of Rheumatology criteria
    - Grade 1-3 radiographic OA as defined by the Kellgren-Lawrence classification
    - Unilateral symptoms
    - Patient is able to complete trial procedures and complete informed consent
    E.4Principal exclusion criteria
    - Knee instability during physical examination (grade II or III)
    - Pre-treatment VAS pain score of <40 of 100
    - Major axial deviation (>10 degrees of valgus or varus deviation)
    - Bilateral symptomatic lesions
    - Current use of anticoagulant medications or NSAIDs used in the 5 days before blood donation
    - Recent intra-articular injection of corticosteroids and prior treatment with HA or PRP in the past 6 months
    - Symptomatic osteoarthritis in the contralateral knee
    - Allergy/sensitivity to study medications or their ingredients
    - Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the initial treatment period
    - Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
    - Known history of, or documented positive hepatitis B or C or HIV infection
    E.5 End points
    E.5.1Primary end point(s)
    WOMAC score: the WOMAC knee score is a 33-question, patient reported, functional outcome measure consisting of 3 domains (Pain: 9 questions; Symptoms & Stiffness: 7 questions; Function daily living: 17 questions). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The WOMAC knee score has been proven to be a robust, practical clinical and research instrument with good responsiveness and acceptability for assessment of knee related OA symptoms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    - WOMAC score
    - EQ-5D-5L score: the EQ-5D-5L is a validated, patient self-report outcome measure which examines five domains related to daily activities: mobility, self-care, usual activities, pain and discomfort and anxiety and depression.
    - VAS score: VAS score is a validated, patient self-report outcome measure which examines pain

    - Rate of adverse events
    - Rate of additional treatments (e.g. need for additional injections or surgery)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3 and 12 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end-of-trial is defined as the date the final follow-up visit (Visit 8) of the last subject.
    The end of study visit for each participant will include:
    - Assessment of outcome measures (WOMAC score and EQ-5D-5L score)
    - Assessment of adverse events
    - Assessment of ongoing symptoms related to knee osteoarthritis requiring further treatment under consultant orthopaedic care. If deemed necessary, patients will be referred to their orthopaedic consultant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state135
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-01
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