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    Summary
    EudraCT Number:2017-000355-46
    Sponsor's Protocol Code Number:Cingal16-02
    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:2017-05-26
    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 number2017-000355-46
    A.3Full title of the trial
    A 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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberCingal16-02
    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.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 Lederlon
    D.2.1.1.2Name of the Marketing Authorisation holderRIEMSER Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Suspension 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 INNTriamcinolone Hexacetonide
    D.3.9.1CAS number 5611-51-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Osteoarthritis of the Knee
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis of the Knee
    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 in subjects with Osteoarthritis (OA) of the knee who have not responded to conservative treatment.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening :
    1. 40-75 years old, Body Mass Index (BMI) ≤ 40 kg/m2.
    2. Kellgren-Lawrence (K-L) severity grade I, II or III in the index knee as determined by X-ray. Contralateral knee: K-L severity grade 0, I or II.
    3. at least two signs and at least two symptoms of OA disease (based on the EULAR recommendations) in the index knee for at least 6 months despite conservative treatment (weight reduction, physical therapy, pain medications, etc.). The EULAR signs and symptoms are as follows:
    o Signs: crepitus, restricted movement and bony enlargement
    o Symptoms: persistent knee pain, limited morning stiffness and reduced function
    4. willing to abstain from other IA treatments of the knee for the duration of the study.
    5. willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study.
    6. willing to use only acetaminophen/paracetamol for the treatment of joint pain for the duration of the study. At least forty eight hours prior to the Baseline Visit and each follow-up visit, willing to discontinue use of acetaminophen/paracetamol.
    7. willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study
    8. able to understand and comply with the requirements of the study and voluntarily provides consent.

    Baseline:
    1. WOMAC pain-sub-score ≥ 40 mm and ≤ 90 mm in the affected knee and ≤ 30 mm in the contralateral knee on a 100 mm Visual Analog Scale (VAS) scale.
    E.4Principal exclusion criteria
    Screening:
    1. received an IA injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either knee during the course of this study.
    2. had an arthroscopy of either knee within 3 months of signing the ICF.
    3. had an open surgical procedure of either knee or hip or any surgery of the spine within 12 months of signing ICF. Subject plans to have knee, hip or spine surgery within the study period.
    4. has intra-articular trauma to the index knee. Subject has concurrent multi-system or multi-limb trauma.
    5. has evidence or medical history of the following diseases in the index knee: septic arthritis; inflammatory joint disease; history of Reiter’s syndrome; gout; chondrocalcinosis associated with recurrent episodes of acute synovitis of the knee consistent with pseudogout; osteochondritis dissecans, Paget disease of the bone; ochronosis; acromegaly; hemochromatosis; primary osteochondromatosis; known history of Wilson disease; heritable disorders or collagen gene mutations.
    6. has a history of cartilage repair surgery in the index knee within 3 years of signing the ICF.
    7. has a history of ACL repair, reconstruction or injury in the index knee within 3 years of signing the ICF.
    8. has X-ray findings of acute fractures, severe bone loss, avascular necrosis, severe bone or joint deformity in the index knee.
    9. has significant varus or valgus deformity greater than 10 degrees in either knee.
    10. has a clinically apparent tense effusion of the index knee.
    11. has knee instability in either knee per the Investigator’s assessment.
    12. requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable.
    13. has medical condition(s) which could affect study assessments or may adversely affect the safety and/or success of the study treatment. (for list of potential conditions refer to protocol)
    14. is taking medications at the time the subjects signs the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
    15. is receiving treatment using electromagnetic stimulation and/or low intensity ultrasound in the index knee at the time of signing the ICF, within 3 months of signing the ICF or plans to receive treatment any time during the study period.
    16. had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index knee only) corticosteroid within 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index knee is allowed.
    17. has a pre-treatment contraindication to IA injections or aspiration of the index knee, including cutaneous infection in the injection site area, active IA infection (as suggested by moderate or marked effusion), knee deformity or condition which, in the opinion of the Investigator could jeopardize the sterility or delivery of the IA injection.
    18. with a history of hypersensitivity to any of the ingredients in the hyaluronan or previous hypersensitivity to the administration of corticosteroids or an inability to tolerate acetaminophen/paracetamol.
    19. has any contraindication to the receipt of a corticosteroid.
    20. is receiving or in litigation for worker’s compensation.
    21. is a woman who is pregnant or breastfeeding at the Screening Visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study.
    22. was involved in any other research study involving an investigational product, or a new application of an approved product, within 60 days of signing the ICF.

    Baseline:
    1. has a decrease of ≥ 20 mm in the WOMAC pain-sub-score (average of 5 pain scales) from Screening to Baseline in the index knee on a 100 mm Visual Analog Scale (VAS) scale.
    2. has a synovial fluid aspirate volume > 20 mL in the index knee.
    3. has a contraindication to continue with the study treatment injection based on the visual appearance of the synovial fluid aspirate unless the fluid is examined microscopically prior to injection with no clinically significant findings (e.g. bacteria, crystals or blood).
    4. has range of motion of less than 100° flexion in either knee.
    E.5 End points
    E.5.1Primary end point(s)
    • The change from baseline in knee pain as measured by the WOMAC Pain Score (100 mm VAS) at 26 weeks post treatment comparing the Cingal group to the TH group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 weeks post treatment
    E.5.2Secondary end point(s)
    * The change from baseline in knee pain as measured by the WOMAC Pain Score (100 mm VAS) at 3 weeks post treatment comparing the Cingal group to the Monovisc group.
    * The responder rate as identified by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder index at 26 weeks post treatment comparing the Cingal group to the TH group.
    * The change from baseline in WOMAC Physical Function score at 26weeks post treatment comparing the Cingal group to the TH group.
    * The change from baseline in WOMAC Stiffness score at 26 weeks posttreatment comparing the Cingal group to the TH group.
    * The change from baseline in Total WOMAC score at 26 weeks post treatment comparing the Cingal group to the TH group.
    * The change from baseline in the Patient Global Assessment at 26 weeks post treatment in the Cingal group compared to the TH group.
    * The change from baseline in the Evaluator Global Assessment at 26 weeks post treatment in the Cingal group compared to the TH group.
    * The change from baseline in knee pain as measured by the WOMAC Pain Score (100 mm VAS) at 1 week post treatment comparing the Cingal group and the Monovisc group.
    *The usage of rescue medication through 26 weeks post treatment in the Cingal group compared to the TH group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3 and 26 weeks post treatment
    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
    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 concerned11
    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
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 state360
    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
    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 Decision2017-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-23
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