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    Summary
    EudraCT Number:2008-003875-35
    Sponsor's Protocol Code Number:GO-ON-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-12
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-003875-35
    A.3Full title of the trial
    Comparative study of efficacy and safety of GO-ON and Hyalgan in patients with symptomatic osteoarthritis of the knee.
    A.4.1Sponsor's protocol code numberGO-ON-01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRottapharm SpA
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 HYALGAN
    D.2.1.1.2Name of the Marketing Authorisation holderFIDIA S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarticular use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Patients with symptomatic osteoarthritis of the knee.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of GO-ON in comparison to Hyalgan on knee pain in patients with symptomatic Knee OA at 26 weeks.
    E.2.2Secondary objectives of the trial
    • to compare the efficacy of GO-ON and Hyalgan on secondary efficacy parameters.
    • to identify Responder patients to the OMERACT-OARSI, MCII and PASS criteria.
    • to evaluate the safety of the studied products in patients with symptomatic knee OA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who fulfilled the following criteria are eligible:
    • patients who signed the informed consent to participate in the study,
    • female/male, age from 50 to 80 year inclusive,
    • patients with femorotibial OA of the knee. The diagnosis of knee osteoarthritis
    will be based on the clinical and radiographic classification criteria developed
    by the American College of Rheumatology (ACR) (Altman R. et al., 1986), i.e.:
    - Knee pain,
    - X-ray osteophytes and
    - at least one of 3:
    age >50 years and/or
    morning stiffness <30 minutes duration
    and/or crepitus on active motion,
    • patients with knee OA symptoms for at least six months and who failed to
    respond (i.e. did not respond sufficiently) to analgesics and/or regular NSAIDs,
    or are proved to be intolerant to the regular use of NSAIDs or weak opioids
    analgesics,
    • patients with a global pain score ≥ to 40 mm on a 0-100 mm VAS and a
    WOMAC pain subscale score ≥ 25 mm on a 0-100 normalized scale,
    • patients with Lequesne’s Index ≥ 4,
    • patients with radiographic stage II or III according to the Kellgren and
    Lawrence radiological classification (the relevant X-ray might have been
    performed within the 12 months preceding the screening visit),
    • patients having X-ray or MRI confirmation of OA in the non-target (contralateral)
    knee, may be enrolled in the trial as long as the target knee is the more
    symptomatic knee and meets the criteria listed above. Pain in the non-signal
    knee must be limited to <30mm at baseline on a 0-100 mm Huskisson VAS,
    • patients treated with SYSADOAs are eligible if the dosage has been stable at
    least three months prior the screening visit
    • patients must be covered by the National Social Security insurance system
    (only for French Patients).
    E.4Principal exclusion criteria
    The main exclusion criteria are the following:
    • isolated or predominantly symptomatic femoropatellar OA of the knee,
    • evidence of secondary osteoarthritis,
    • rheumatic diseases other than osteoarthritis,
    • with “clinical joint effusion” of the target knee on the day of screening,
    • history of allergy or known hypersensitivity to hyaluronic acid and/or hypersensitivity to any of the components of the products under study,
    • patients in which both rescue medications (paracetamol/NSAID) are contraindicated,
    • any significant health problem,
    • known hepatic function abnormalities,
    • skin infection or disease at the injection site,
    • use of any experimental drug within the previous 3 months,
    • obese patients (BMI ≥32),
    • patients who have been treated with:
    - intra-articular steroid during the previous month or systemic steroid drugs within the 3 months preceding randomization and/or
    - intra-articular hyaluronic acid in the target knee during the previous 12 months,
    • ongoing anticoagulant treatment (except patients on low dose aspirin, not exceeding 325 mg per day),
    • patients with symptomatic hip OA homolateral to the target knee,
    • pregnant or lactating women, and women of childbearing potential (using adequate contraceptive method for at least 1 year) not willing to keep on using adequate contraceptive method for the duration of the study,
    • perceived inability/unwillingness to fully comply with all protocol requirements.
    • Patients who underwent extensive surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) and/or uncomplicated meniscectomy if performed within the last 12 months before the screening visit of the target knee. [Even if meniscectomy is a RISK FACTOR for knee OA, it is not considered an exclusion criteria if performed > 12 months before the screening visit].
    • Patients who have received any investigational drug/device within 3 months prior to the screening visit and/or patients who are scheduled to take part in other clinical trial during the course of this trial.
    • Patients with a severe concomitant disease at any organ or apparatus (including acute or chronic infective diseases) that may interfere with the free use and evaluation of the affected knee for the 6 months course of the trial and/or current treatment or treatment within the previous 2 years prior to the screening visit for any malignancy (excluding basal cell or squamous cell carcinoma of the skin).
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the statistical analysis will be the assessment of non-inferiority of GO-ON with respect to Hyalgan in the control of knee pain, 26 weeks after the first injection. Mean variation of the mean WOMAC pain (rated on a 0 – 100 mm Visual Analogue Scale), calculated on the PP population, will be used as primary efficacy parameter.
    GO-ON will be declared non-inferior to Hyalgan, rejecting the Null Hypothesis, if the lower limit of the 95% Confidence Interval of the difference will lie above the lower equivalence (non-inferiority) margin (-9 mm).
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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
    Medical Device
    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 concerned27
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 Information not present in EudraCT
    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
    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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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 Decision2008-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-17
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