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    Summary
    EudraCT Number:2019-000809-71
    Sponsor's Protocol Code Number:APPI2-PT-2019-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-16
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-000809-71
    A.3Full title of the trial
    Direct comparison of intra-articular saline injections with an education plus exercise program for treatment of knee osteoarthritis symptoms: A randomised, open label, controlled, evidence based trial
    Sammenligning af saltvandsindsprøjtning i knæ med et undervisnings- og træningsprogram til behandling af symptomer ved knæartrose: Et lodtrækningsforsøg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Saline injections versus Education and Exercise in knee osteoarthritis
    Sammenligning af saltvandsinjektioner i knæleddet med et undervisnings og træningsprogram til behandling af symptomer ved knæartrose: Et randomiseret åben-label, kontrolleret, evidensbaseret forsøg.
    A.3.2Name or abbreviated title of the trial where available
    DISCO
    A.4.1Sponsor's protocol code numberAPPI2-PT-2019-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03843931
    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 SponsorThe Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
    B.1.3.4CountryDenmark
    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 supportthe Oak Foundation
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportLundbeckfonden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDanish Association of Physiotherapists
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
    B.5.2Functional name of contact pointPrimary/ Principal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressNordre Fasanvej 57, Vej 8, Indg. 19
    B.5.3.2Town/ cityFrederiksberg, Copenhagen
    B.5.3.3Post code2000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4538164155
    B.5.5Fax number4538164159
    B.5.6E-mailhenning.bliddal@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 Natriumklorid isotonisk "SAD"
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    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
    Knæartrose
    E.1.1.1Medical condition in easily understood language
    Knee osteoarthritis
    Knæartrose (slidgigt)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10031165
    E.1.2Term Osteoarthritis knee
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare a widely used education plus exercise program (the GLA:D
    program) with intra-articular saline injections as treatments of knee OA
    symptoms
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥50 years.
    - Body Mass index ≤ 35
    - A clinical diagnosis of tibiofemoral OA in the target knee according to the American College of Rheumatology.
    - Average knee pain in the last week during weight bearing activities of at least 4 on a 0 to 10 points scale (0=no pain; 10=worst possible pain).
    - Verification of clinical diagnosis by definite tibiofemoral OA on posterior-anterior weight bearing semi-flexed knee radiographs with severity equivalent to Kellgren and Lawrence grade 2 or more.
    E.4Principal exclusion criteria
    - Intra-articular treatments of any kind of either knee 3 months before inclusion
    - Scheduled surgery during study participation
    - Knee joint fluid aspiration within 3 month of baseline visit
    - Participation in exercise therapy within 3 months of baseline visit
    - Evidence of other inflammatory joint disease (e.g. rheumatoid arthritis or gout)
    - History of knee surgery within 12 months
    - History of arthroplasty in the target knee
    - Use of oral glucocorticoids
    - Use of synthetic or non-synthetic opioids
    - Other musculoskeletal, neurological, medical conditions precluding participation in exercise
    - Contraindications to intra-articular injections, such as wounds or skin rash over injection site.
    - Contraindications to exercise
    - Planning to start other treatment for knee OA in the study participation period
    - Regional pain syndromes
    - Generalised pain syndromes such as fibromyalgia
    - Lumbar or cervical nerve root compression syndromes
    - Pregnancy or insufficient anti-conception therapy for female fertile patients
    - Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as large knee joint effusion, uncontrolled diabetes, psychiatric disorders, or opiate dependency.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is change from baseline in the Knee injury and
    Osteoarthritis Outcome Score (KOOS) pain subscale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 9 weeks
    E.5.2Secondary end point(s)
    - Change from baseline in the function, symptoms, knee-related quality of life, function in sports and recreational activity subscales of the KOOS questionnaire at week 9 and 12
    - Change from baseline in patient's global assessment of impact of osteoarthritis at week 9 and 12
    - Number of treatment responders as per the OMERACT-OARSI response criteria at week 9 and 12
    - Change from baseline in 4x10 meter fast walk test at week 9 and 12
    - Change from baseline in the 30 seconds chair stand test at week 9 and 12
    - Change from baseline in Stair climbing test at week 9 and 12
    - Joint aspiration volume at week 9 and 12
    - Change from baseline in swollen knee joint count at week 9 and 12
    - Change in knee pain at treatment visits
    - Time course pattern of changes from baseline in knee OA symptoms assessed by repeated administration of the KOOS questionnaire at weeks 1, 2, 3, 4, 5, 6, and 7
    - Change from baseline in weekly average morning knee pain at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 12
    - Change from baseline in the intermittent and constant osteoarthritis pain score (ICOAP questionnaire) at week 9 and 12
    - Patient reported (diary) paracetamol and ibuprofen use at week 9 and 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 9 weeks (all outcomes).
    After 12 weeks (questionnaires+diary, clincal exams, physical tests and joint aspiration).
    At week 1, 2, 3, 4, 5, 6, 7, 8 (KOOS questionnaire and morning pain questionnaire)
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Education and Exercise
    E.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state200
    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 Decision2019-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-18
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