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    Summary
    EudraCT Number:2017-003205-18
    Sponsor's Protocol Code Number:Cingal17-02
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-09
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-003205-18
    A.3Full title of the trial
    Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal®) to Provide Symptomatic Relief of Osteoarthritis of the Knee
    Przedłużenie badania Cingal 16-02: Przedłużenie badania do 39 tygodni obserwacji w wieloośrodkowym, randomizowanym, prowadzonym metodą podwójnie ślepej próby, z kontrolą aktywnego produktu porównawczego, badaniu dotyczącym podania w postaci pojedynczego wstrzyknięcia usieciowanego hialuronianu sodu w połączeniu z heksacetonidem triamcynolonu (Cingal®) w celu złagodzenia objawów choroby zwyrodnieniowej stawu kolanowego
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial Extension to 39 Week Follow Up in the Randomized, Blinded Trial to compare a Single Injection of Cingal® (Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide) with Cross-Linked Sodium Hyaluronate alone and with Triamcinolone Hexacetonide alone for Providing Symptomatic Relief of Osteoarthritis of the Knee
    Przedłużenie badania do 39 tygodni obserwacji w randomizowanym, zaślepionym badaniu mającym na celu porównanie pojedynczego wstrzyknięcia Cingal® (usieciowanego hialuronianu sodu w połączeniu z heksacetonidem triamcynolonu) z samym usieciowanym hialuronianem sodu i z samym heksacetonidem triamcynolonu w celu złagodzenia objawów choroby zwyrodnieniowej stawu kolanowego
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberCingal17-02
    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 SponsorAnika Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportAnika Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnika Therapeutics, Inc.
    B.5.2Functional name of contact pointDirector of Clinical Affairs
    B.5.3 Address:
    B.5.3.1Street Address32 Wiggins Avenue
    B.5.3.2Town/ cityBedford
    B.5.3.3Post codeMA 01730
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1781 457 9226
    B.5.6E-mailAOrr@AnikaTherapeutics.com
    D. IMP Identification
    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
    Osteoarthritis of the Knee
    Choroba zwyrodnieniowa stawów kolanowych
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis of the Knee
    Choroba zwyrodnieniowa stawów kolanowych
    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 evaluate the efficacy and safety of a single injection of Cingal for relief of joint pain at 39 week follow up in subjects with Osteoarthritis (OA) of the knee who have not responded to conservative treatment.
    Ocena skuteczności i bezpieczeństwa pojedynczego wstrzyknięcia preparatu Cingal po 39 tygodniu obserwacji w łagodzeniu bólu stawu u pacjentów z chorobą zwyrodnieniową stawu kolanowego, niereagujących na leczenie zachowawcze.
    E.2.2Secondary objectives of the trial
    N/A
    Nie dotyczy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects meet the inclusion criteria for Cingal 16-02 and signed the informed consent.
    2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.

    Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.
    1. Pacjenci spełniają kryteria włączenia do badania Cingal 16-02 i podpisali świadomą zgodę.
    2. Pacjent musi być zdolny do zrozumienia i przestrzegania wymagań związanych z badaniem Cingal 17-02, a także musi dobrowolnie wyrazić zgodę.

    Pacjenci nie będą ponownie poddawani badaniom przesiewowym podczas włączania do badania Cingal 17-02, ponieważ spełniają oni kryteria włączenia/wykluczenia dotyczące badania klinicznego Cingal 16-02.
    E.4Principal exclusion criteria
    Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.

    All patients enrolled in the Cingal 16-02 trial will be eligible to participate in Cingal 17-02.
    Pacjenci nie będą ponownie poddawani badaniom przesiewowym podczas włączania do badania Cingal 17-02, ponieważ spełniają oni kryteria włączenia/wykluczenia dotyczące badania klinicznego Cingal 16-02.

    Wszyscy pacjenci włączeni do badania Cingal 16-02 będą się kwalifikowali do udziału w badaniu Cingal 17-02.
    E.5 End points
    E.5.1Primary end point(s)
    • The responder rate as identified by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder index at 39 weeks post treatment comparing the Cingal group to the TH group.
    Odsetek odpowiedzi na leczenie, obliczony jako wskaźnik odpowiedzi przy wykorzystaniu wskaźników oceny wyników badań klinicznych nad reumatoidalnym zapaleniem stawów Międzynarodowego Towarzystwa Badań Choroby Zwyrodnieniowej Stawów (OMERACT-OARSI) 39 tygodni po leczeniu w grupie przyjmującej Cingal w porównaniu z grupą przyjmującą TH.
    E.5.1.1Timepoint(s) of evaluation of this end point
    39 weeks post treatment
    39 tygodni po leczeniu
    E.5.2Secondary end point(s)
    • The change from baseline in knee pain as measured by the WOMAC Pain Score (100 mm VAS) at 39 weeks post treatment comparing the Cingal group to the TH group.
    • The change from baseline in the Patient Global Assessment 39 weeks post treatment in the Cingal group compared to the TH group.
    • The change from baseline in the Evaluator Global Assessment at 39 weeks post treatment in the Cingal group compared to the TH group.
    Zmiana w stosunku do punktu wyjściowego wartości nasilenia bólu stawu kolanowego określana na podstawie wyniku oceny w skali bólu kwestionariusza WOMAC (przy użyciu skali VAS 100 mm) w okresie 39 tygodni po leczeniu w grupie preparatu Cingal w porównaniu z grupą TH.
    • Zmiana w stosunku do punktu wyjściowego w wyniku ogólnej samooceny pacjenta 39 tygodni po leczeniu w grupie preparatu Cingal w porównaniu z grupą TH.
    • Zmiana w stosunku do punktu wyjściowego w wyniku ogólnej oceny dokonywanej przez osobę oceniającą 39 tygodni po leczeniu w grupie preparatu Cingal w porównaniu z grupą TH.
    E.5.2.1Timepoint(s) of evaluation of this end point
    39 weeks post treatment
    39 tygodni po leczeniu
    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) Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    inny wyrób medyczny
    other medical device
    E.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial 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: 519
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 state417
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 576
    F.4.2.2In the whole clinical trial 576
    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
    Brak
    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 Decision2018-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-08
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