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    Summary
    EudraCT Number:2015-002924-17
    Sponsor's Protocol Code Number:CLR_15_05
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-01-27
    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 number2015-002924-17
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberCLR_15_05
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02534896
    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 SponsorSun Pharma Global FZE
    B.1.3.4CountryUnited Arab Emirates
    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 supportSun Pharma Global FZE
    B.4.2CountryUnited Arab Emirates
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSun Pharma Global FZE
    B.5.2Functional name of contact pointManager Business Development
    B.5.3 Address:
    B.5.3.1Street AddressOffice No. 43, Block-Y, SAIF Zone
    B.5.3.2Town/ citySharjah
    B.5.3.3Post codeP.O. Box No. 12
    B.5.3.4CountryUnited Arab Emirates
    B.5.4Telephone number9714454 8627
    B.5.5Fax number9714454 8465
    B.5.6E-mailvishwanath.kenkare@sunpharma.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 No
    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.3.1Product nameNanocort
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNprednisolone
    D.3.9.3Other descriptive namePREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeliposomal encapsulated active substance (Prednisolone Sodium Phosphate)
    D.IMP: 2
    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 Depo Medrol
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameDepo Medrol
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    To assess efficacy and safety (treatment of signs and symptoms) of Nanocort in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation in comparison to a standard of care medication (Depo-Medrol).
    E.2.2Secondary objectives of the trial
    Patient Reported Outcomes and an assessment of pharmacokinetic parameters in a subset population from each treatment group.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PK substudy in 45 patients, described in full protocol CLR_15_05 version 2.0.
    E.3Principal inclusion criteria
    1) Male or female ≥ 18 years old.
    2) Known Diagnosed RA according to the revised 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria. Secondary Sjögren’s syndrome with RA is permitted.
    3) Male and female subjects with active RA who are experiencing a flare / exacerbation defined as a recent increase in symptoms and a measured increase in DAS28 > 1.2 or > 0.6 if DAS28 ≥ 3.2 compared to last DAS28 measurement (maximum 6 months before). The increase in DAS28 has to be RA related.
    4) Willing and able to comply with the study protocol visits, assessments and accessible for follow up.
    5) Subjects naïve to treatment and/or currently not treated for at least 8 Weeks prior to the Screening Visit and willing to continue without non-study treatment for 12 Weeks, or subjects on stable treatment with DMARD (including biologicals) for at least 8 Weeks prior to the Screening Visit and willing to continue current stable treatment for 12 Weeks.
    6) Subjects able and willing to give written informed consent (or legally acceptable representative or impartial witness when applicable) and is available for entire study.
    7) Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (e.g., Depo Provera™), an intrauterine device, vasectomized partner, an oral contraceptive taken continually within the past three months and which the subject agrees to continue using during the study.
    8) Male subjects enrolled in the study are advised to prevent passage of semen to their sexual partner during intercourse using acceptable methods as judged by the investigator.
    E.4Principal exclusion criteria
    1) Rheumatic autoimmune disease other than RA, e.g., systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis.
    2) Current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, spondyloarthritis, Lyme disease, osteoarthritis).
    3) Subjects who are pregnant or intend to become pregnant during the study.
    4) Have a family history (more than one first degree relative) of multiple thrombotic events or a personal history of any venous or arterial thrombotic event including deep vein thrombosis, stroke, myocardial infarction, pulmonary embolus, and peripheral arterial thromboembolic events or abnormal ECG which may impact the subject’s safety as per Investigator’s opinion.
    5) Subject with positive hepatitis panel (including hepatitis B surface antigen [HBsAg], and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency virus (HIV) antibody screen, based on the current medical data of the patient.
    6) Abnormal hepatic function [alanine aminotransferase (ALT)/aspartate aminotransferase (AST) or bilirubin > 2 x upper limit of normal] at the time of the Screening Visit.
    7) Abnormal renal function [Blood Urea Nitrogen (BUN) or creatinine >1.25 x upper limit of normal] at the time of the Screening Visit.
    8) Clinically significant out-of-range values on hematology panel, at discretion of the PI.
    9) Treatment with oral, rectal or injectable (including intra-articular) glucocorticoids (GCs) within 8 Weeks prior to Screening Visit. Inhaled glucocorticoids are allowed. Topical steroids are allowed, however subjects should not have received more than 100 gram of a mild to moderate topical corticosteroid cream per Week, 50 gram of a potent corticosteroid cream per Week or 30 gram of a very potent topical corticosteroid cream per Week in the 4 Weeks prior to the Screening Visit.
    10) Subjects who have received an investigational drug within 30 Days prior to the Screening visit.
    11) Previous treatment with IV gamma globulin, plasmapheresis or Prosorba® column within 3 months prior to Screening.
    12) Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to IV medications, biologic therapy or IV radiocontrast agents.
    13) Contraindication for glucocorticoids as judged by Investigator.
    14) Subjects who have previously received Nanocort.
    15) Neuropathies or other painful conditions that might interfere with pain evaluation, as judged by the Investigator.
    16) Active infection requiring systemic treatment.
    17) Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.
    18) Requirement for immunizations or vaccinations during the study period.
    19) Subjects with poor peripheral venous access as per Investigator or site personnel opinion.
    20) History of substance abuse or alcohol abuse.

    Additional exclusion criteria for subjects participating in PK subset study:
    Blood donation by subjects within 6 months before screening.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint: European League Against Rheumatism (EULAR) responder (moderate and good combined) rate at Week 1 (Day 8)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 1 (Day 8)
    E.5.2Secondary end point(s)
    Key Secondary Endpoints:
    • EULAR responder (only good) rate at Week 1 (Day 8)
    • EULAR responder (moderate and good combined) rate at Week 2 (Day 15)
    • EULAR responder (only good) rate at Week 2 (Day 15)

    Secondary endpoints:
    • EULAR response at Week 1, 2, 3, 4, 6, 8 and 12
    • DAS28 mean and % change at Week 1, 2, 3, 4, 6, 8 and 12
    • Time to first EULAR response (moderate/good)
    • ACR 20/50/70 response scores at Week 1, 2, 3, 4, 6, 8 and 12
    • Tender joint counts at Week 1, 2, 3, 4, 6, 8 and 12
    • Swollen joint counts at Week 1, 2, 3, 4, 6, 8 and 12
    • Patient pain and Global Visual Analog Score (VAS) score at Week 1, 2, 3, 4, 6, 8 and 12
    • Investigator Global Visual Analog Score (VAS) score at Week 1, 2, 3, 4, 6, 8 and 12
    • Short Form 36 (SF-36) to assess physical and mental component at Week 1, 2, 4, 6, and 12.
    • Health Assessment Questionnaire (HAQ) at Week 1, 2, 3, 4, 6, 8 and 12.
    • The Functional Assessment of Chronic Illness Therapy (FACIT) at Baseline, Week 4 and 6
    • Health Economics Questionnaire at Week 12
    • Maintenance of Improvement at 12 Weeks assessed during a blinded review by the Medical Monitor (MM) and Principal Investigator (PI) at the end of the study
    • AEs (including glucocorticoid related AEs, AEs leading to withdrawal, AEs leading to discontinuation of medication, and AEs due to infusion reactions)
    • Vital signs
    • Physical examinations
    • Laboratory
    • ECG
    • Pharmacokinetics assessment in subset of patient population at Baseline, Week 1, 2, 3, 4 and 6
    • Assessment by monitoring cortisol levels at Screening, Baseline, 6 and 12 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    dubble dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA25
    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 years
    E.8.9.1In the Member State concerned months17
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months17
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 330
    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 Decision2016-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-06-13
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