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    Summary
    EudraCT Number:2011-002392-41
    Sponsor's Protocol Code Number:Z102-009
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-07
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2011-002392-41
    A.3Full title of the trial
    A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.
    A.4.1Sponsor's protocol code numberZ102-009
    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 SponsorZalicus, 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 supportZalicus, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1000 Continental Drive
    B.5.3.2Town/ cityKing of Prussia
    B.5.3.3Post codePA 19406
    B.5.3.4CountryUnited States
    B.5.4Telephone number+001 610 9642012
    B.5.5Fax number+0016102250050
    B.5.6E-mailmeera.jessani@wwctrials.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 nameZ102
    D.3.2Product code Z102
    D.3.4Pharmaceutical form Capsule
    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 INNPrednisolone
    D.3.9.1CAS number 52438-85-4
    D.3.9.2Current sponsor codePrednisolone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDipyridamole
    D.3.9.1CAS number 58-32-2
    D.3.9.2Current sponsor codeDipyridamole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number360
    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.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 Dacortin ®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, S.L.
    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.3.1Product namePrednisone
    D.3.4Pharmaceutical form Capsule
    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 INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5.0 to 7.5
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of patients with moderate to severe rheumatoid arthritis (RA)
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety of Z102 relative to standard glucocorticoid comparators (5.0 mg and 7.5 mg prednisone) over a 12-month period in patients with RA using the following assessment tools:
    o Adverse events
    o Vital signs
    o Clinical laboratory and clinical chemistry evaluations
    o Physical examination and body weight
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of Z102 relative to standard glucocorticoid comparators (5.0 mg and 7.5 mg prednisone) over a 12-month period in patients with RA using the following assessment tools:
    o Joint imaging and bone density using plain radiography and dual-energy X-ray absorptiometry (DXA)
    o Disease Activity Score 28 (DAS28)- C-reactive protein (CRP) and individual components
    o American College of Rheumatology (ACR) 20, ACR 50, and ACR 70
    o Multidimensional Assessment of Fatigue (MAF)
    o Time to failure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Prior to Screening, have voluntarily signed the Informed Consent Form. Completing patients from Protocol Z102-008 will sign informed consent for Protocol Z102-009 prior to their termination visit in Protocol Z102-008.
    2. Have completed all 12 weeks of Protocol Z102-008 or discontinued after participating in at least 6 weeks of the randomized withdrawal portion of Z102-008 for acceptable reasons (i.e., for reasons other than Adverse Event (AE), protocol violation, or non-compliance). If Protocol Z102-008 participation terminated early, the full 12-week period (inclusive of study participation period) must elapse before participants in Z102-008 may be considered for participation in the 52-week extension study (Z102-009).
    3. Have met all inclusion/exclusion criteria for enrollment into Protocol Z102-008.
    4. Have been on DMARD therapy for at least 90 days and have been on a stable DMARD dose without dosage adjustment or modification for 6 weeks prior to enrollment into Protocol Z102-008, and be able to maintain the same dose of conventional DMARD therapy during Protocol Z102-009 participation (with or without glucocorticoid therapy); stable DMARD therapy may include a combination of DMARD agents (methotrexate and azulfidine or methotrexate and hydroxychloroquine as examples).
    5. At Screening, female patients of childbearing potential (18 to 55 years of age, inclusive) must have negative urinary human chorionic gonadotropin (hCG) tests.
    6. Female patients of childbearing potential (18 to 55 years of age, inclusive) must use acceptable methods of birth control (including, but not limited to, intrauterine device [IUD], oral or injectable contraceptives, barrier methods, or abstinence) for the duration of Protocol Z102-009.
    7. If currently taking the following medications, she/he has been on a stable dose of the same drug for at least 3 months prior to entering into Protocol Z102-008, continued on the same dose during Protocol Z102-008, and should be able to continue on the same dose for the duration of Protocol Z102-009: statins, diuretics, thyroid hormone, hypoglycemic medications, and cardiovascular medications.
    8. Have no general or specific changes in his/her condition unacceptable for further treatment in the judgment of the investigator.
    E.4Principal exclusion criteria
    1. Did not complete 6 weeks of the double-blind section of Protocol Z102-008, or was discontinued from Protocol Z102-008 for reasons of an AE, protocol violation, or non-compliance.
    2. Female patient who is pregnant or lactating or of childbearing potential not using acceptable methods of birth control (including, but not limited to, IUD, oral or injectable contraceptives, barrier methods, or abstinence).
    3. Patients who do not respond to therapies that include a dose less than 10 mg prednisone and either a DMARD combination, DMARD/biologic combination, or biologics alone.
    4. Active cardiovascular disease, unless well controlled by appropriate treatment, for a minimum of 3 months prior to screening for enrollment into Protocol Z102-008.
    5. Currently taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg.
    6. Taking oral steroids at a daily prednisone dose, or the equivalent, of >10 mg/day within the past 2 weeks.
    7. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering study Protocol Z102-008 or Protocol Z102-009, at any time during the study, or be anticipated to be given at any time during the study.
    8. The need to continue the use of one or multiple NSAIDs at the same time, or use acetaminophen on a chronic basis. Acetaminophen/paracetamol is permitted episodically for pain during the titration and stable dose treatment period for Protocol Z102-009, not exceeding 1.5 g/day for any 3 days in any 7-day interval. There are no exclusions during the 30-day follow-up period.
    9. All opiate use is prohibited. Such agents include oxycodone, hydrocodone, codeine, morphine sulfate, Demerol (meperidine/pethidine), Dilaudid (hydromorphone), tramadol, combination products including Percocet (oxycodone and acetaminophen), Hydrocet (dihydrocodeine and acetaminophen), Tylenol (acetaminophen or paracetamol) with codeine, Vicodin (hydrocodone and acetaminophen), Lorcet (hydrocodone and acetaminophen), Lortabs (hydrocodone and acetaminophen) extended-release formulations.
    10. Use of any other medications or herbs or non-pharmacological treatments (e.g., acupuncture) used for the treatment of pain is prohibited.
    11. Excluded medications include systemic anticoagulants, including dipyridamole, Coumadin (warfarin), clopidogrel, ticlopidine, and aspirin exceeding 325 mg/day (whether or not taken for cardiovascular prophylaxis). All systemic antifungal agents are excluded, including (but not limited to) the polyene macrolides (amphotericin B), the azoles (ketoconazole, miconazole, itraconazole, and fluconazole), and the allylamines (terbinafine). All anti-HIV drugs belonging to the following classes are prohibited: members of the nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside/nucleotide reverse transcriptase inhibitors, protease inhibitors, fusion and entry inhibitors, and integrin inhibitors. These agents include (but are not limited to) abacavir, zidovudine, didanosine, tenofovir, and efavirenz.
    12. Has, or has had any active severe infections, such as osteomyelitis, sepsis, active infectious hepatitis, endocarditis, systemic fungal infection, or recent invasive surgical procedures within 30 days of Protocol Z102-008 or Protocol Z102-009 initiation.
    13. Known HIV, hepatitis B, or hepatitis C infection.
    14. Has undergone administration of any investigational drug within 30 days of study Protocol Z102-008 initiation, and within 30 days of Protocol Z102-009 initiation, other than Protocol Z102-008, or intends to participate in any investigational drug trial during the study.
    15. All biologic agents are excluded for 90 days prior to Screening and during the conduct of Protocol Z102-008, and Protocol Z102-009.
    16. Has undergone administration of rituximab or any B-cell depleting investigational drugs within 6 months of Protocol Z102-008 Screening or Protocol Z102-009 initiation, or at any time during participation in study Protocol Z102-008, and throughout the conduct of Protocol Z102-009.
    17. Has a history of hypersensitivity reaction to glucocorticoids and/or dipyridamole.
    18. Known or suspected history of alcohol or drug abuse within 2 years prior to Screening for Protocol Z102-008.
    19. Has any other medical condition which may interfere with the conduct of this study in the opinion of the investigator.
    20. Has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding AEs cannot be provided.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the safety of Z102 relative to standard glucocorticoid comparators (5.0mg and 7.5mg prednisone) over a 12 month period in patients with Rheumatoid Arthritis (RA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to month 12
    E.5.2Secondary end point(s)
    To evaluate the efficacy of Z102 relative to standard glucocorticoid comparators (5.0mg and 7.5mg prednisone) over a 12 month period in patients with Rheumatoid Arthritis (RA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to month 12
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Bulgaria
    Canada
    Chile
    Hungary
    Mexico
    Peru
    Poland
    Russian Federation
    Serbia
    Ukraine
    United States
    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
    Following the last patient-last dose, the completion of the 2 week follow-up of this patient represents the end of trial.
    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 months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days15
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 200
    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)
    The physician will determine the appropriate care for the patient following the end of the trial. There is currently no provision for named patient supplies.
    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 Decision2012-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-08
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