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    Summary
    EudraCT Number:2015-005681-37
    Sponsor's Protocol Code Number:CL/BIO/15-005
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-005681-37
    A.3Full title of the trial
    Evaluation of the evolution of imaging markers of cartilage degradation in patients with knee osteoarthritis receiving DROGLICAN®: a Pilot Study
    Evaluation de l'évolution des marqueurs d'imagerie de la dégradation du cartilage chez les patients atteints d'arthrose du genou recevant du DROGLICAN®: Etude Pilote
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the evolution of imaging markers (using Magnetic Resonnance Imaging) of cartilage degradation in patients with knee osteoarthritis receiving DROGLICAN®: a Pilot Study
    Evaluation de l'évolution des marqueurs d'imagerie (par Imagerie par Résonnance Magnétique) de la dégradation du cartilage chez les patients atteints d'arthrose du genou recevant du DROGLICAN®: Etude Pilote
    A.3.2Name or abbreviated title of the trial where available
    DRIP
    DRIP
    A.4.1Sponsor's protocol code numberCL/BIO/15-005
    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 SponsorBIOIBERICA S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBIOIBERICA S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARTIALIS S.A.
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de l'Hôpital, 11
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.6E-mailinvestigators_clinicaltrials@artialis.com
    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 DROGLICAN
    D.2.1.1.2Name of the Marketing Authorisation holderBIOIBERICA S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucosamine Hydrochloride
    D.3.9.1CAS number 66-84-2
    D.3.9.2Current sponsor codeGH
    D.3.9.3Other descriptive nameGLUCOSAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02354MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChondroitin Sulfate
    D.3.9.1CAS number 9082-07-9
    D.3.9.2Current sponsor codeCS
    D.3.9.3Other descriptive nameCHONDROITIN SULFATE
    D.3.9.4EV Substance CodeSUB13355MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Arthrose du genou
    E.1.1.1Medical condition in easily understood language
    Knee osteoarthritis
    Arthrose du genou
    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 primary objective is to evaluate the evolution of dGEMRIC imaging marker after 6 months of treatment with DROGLICAN®
    E.2.2Secondary objectives of the trial
    • Use of rescue treatments (Paracetamol, tramadol and oral NSAIDs excluding COX2 inhibitors)
    • Option: evolution of dGEMRIC imaging marker after 12 months of treatment with DROGLICAN®
    • Option: evolution of cartilage and bone parameters (volume, thickness, curvature, lesions, etc.) after 6 and 12 months of treatment with DROGLICAN®
    • Option : evolution of Joint Space Width (JSW)after 12 months of treatment with DROGLICAN®
    • Tolerance
    • Compliance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female ≥ 40 years of age with BMI ≤ 40
    • Femorotibial knee OA (Uni- or bilateral)
    o Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
    o Symptomatic for more than 6 months in the most painful knee
    o Radiological K&L grade II-III in radiographs from less than 12 months
    • Moderate-to-severe knee pain: knee pain score evaluated on VAS (0-100) ≥ 40 over the last 24 hours at the inclusion visit (the most painful knee is considered)
    • Able to follow the instructions of the study
    • Having signed an informed consent
    • Homme ou femme de ≥ 40 ans avec un IMC ≤ 40
    • Gonarthrose fémoro-tibiale (uni- ou bilatérale) :
    o Répondant aux critères cliniques et radiologiques de l'ACR (American College of Rheumatology)
    o Symptomatique depuis plus de 6 mois pour le genou le plus douloureux
    o Grade radiologique K&L II ou III sur des radiographies datant de moins de 12 mois
    • Douleur du genou modérée à sévère au cours des dernières 24 heures évaluée sur une EVA (0-100) ≥ 40, durant la visite d’inclusion. Le genou le plus douloureux est pris en compte.
    • Capable de suivre les instructions de l'étude
    • Ayant signé un consentement éclairé
    E.4Principal exclusion criteria
    Related to the OA pathology
    • Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
    • Concurrent articular disease interfering with the evaluation of OA and/or pain such as articular dysplasia, aspectic osteonecrosis, acromegaly, Paget’s disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis, etc.
    • Radiological K&L grade I or IV
    • Prosthesis in the target knee

    Related to treatments
    • Analgesics to manage OA knee pain (Paracetamol, oral NSAIDs, etc.) 24h before inclusion and any follow-up visits
    • Corticosteroids injection in the target knee in the month preceding inclusion
    • Hyaluronan injection in the target knee in the last 6 months
    • Oral corticotherapy ≥ 5mg/day in the last 3 months
    • Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
    • An anticipated need for any OA related medication for the duration of the trial (Corticosteroids or hyaluronan injection, Oral corticotherapy, Arthroscopy) which are forbidden during the trial
    • Arthroscopy in the last 6 months
    • Patients with known allergy to CS, GH, or intolerance to rescue treatments (Paracetamol, tramadol and NSAIDs)
    • Patients with allergy to shellfish

    Related to associated diseases
    • Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, tumor, HIV….)
    • Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee

    Related to patients
    • Artialis (study coordinator) or Bioiberica (Sponsor) ‘s employees
    • Participation to a therapeutic clinical trial in the last 3 months
    • Under guardianship or judicial protection
    • Pregnancy, breastfeeding, planned conception
    • Women without menopause or tubal ligation and without contraception

    Related to MRI
    • Unable to receive gadopentetate contrast agent injection because of contraindications:
    o Acute or chronic severe renal insufficiency (a glomerular filtration rate < 30 mL/min/1.73m2); or
    o Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period.
    • Known anaphylactic reactions to Gadolinium or related substances
    • Risk groups for MRI scanning due to magnetic field or contrast agent: Metal in body: Pacemaker / AICD / ICD (coronary defibrillator), Nervus vagus stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insuline pump, Metal implants; f/e screws, prostheses, piercings.
    • Claustrofibia, or serious mobility problem (Parkinson, tremors)
    E.5 End points
    E.5.1Primary end point(s)
    dGEMRIC index
    Indice dGEMRIC
    E.5.1.1Timepoint(s) of evaluation of this end point
    V0 = Inclusion visit
    V1 = After 6 months of treatment
    V2 = After 12 months of treatment (option)
    V0 = Visite d'inclusion
    V1 = Après 6 mois de traitement
    V2 = Après 12 mois de traitement (option)
    E.5.2Secondary end point(s)
    • Option: cartilage/bone parameters (volume, thickness, curvature, lesions, etc.)
    • Option : radiographic JSW
    • Adverse events and drop-out
    • Rescue treatments (Paracetamol, tramadol and oral NSAIDs excluding COX2 inhibitors)
    • Pill count and compliance assessment by phone call
    E.5.2.1Timepoint(s) of evaluation of this end point
    V0 = Inclusion visit
    V1 = After 6 months of treatment
    V2 = After 12 months of treatment
    V0 = Visite d'inclusion
    V1 = Après 6 mois de traitement
    V2 = Après 12 mois de traitement
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    DVDP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    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
    Aucun
    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 Decision2016-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-19
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