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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-000261-12
    Sponsor's Protocol Code Number:CNTO328MDS2001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-31
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-000261-12
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter
    Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus
    Best Supportive Care in Anemic Subjects with International Prognostic
    Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects with International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome
    A.4.1Sponsor's protocol code numberCNTO328MDS2001
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group, Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31071 524 21 66
    B.5.5Fax number31071524 21 10
    B.5.6E-mailClinicalTrialsEU@jnj.its.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 nameSiltuximab
    D.3.2Product code CNTO328
    D.3.4Pharmaceutical form Powder 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 INNSiltuximab
    D.3.9.2Current sponsor codeCNTO328
    D.3.9.3Other descriptive nameChimeric murine human anti-IL-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) 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 Yes
    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 typemonoclonal antibody
    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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemia associated with Low- or Intermediate-1-Risk Myelodysplastic
    Syndrome
    E.1.1.1Medical condition in easily understood language
    Myelodysplastic Syndrome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10028534
    E.1.2Term Myelodysplastic syndrome NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10002272
    E.1.2Term Anemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic 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
    The primary objective is to assess the clinical efficacy of siltuximab,
    demonstrated by a reduction in RBC transfusions to treat the anemia of
    MDS.
    E.2.2Secondary objectives of the trial
    • To demonstrate symptomatic improvement of subjects treated with siltuximab compared with the placebo group
    • To compare the number of RBC units transfused to treat the anemia of MDS, and the proportion of subjects treated with siltuximab who do not require a RBC transfusion to treat the anemia of MDS, from Week 5 to Week 12, compared with the placebo group
    • To assess the change in hemoglobin among MDS subjects treated with siltuximab compared with the placebo group
    • To compare disease progression (proportion of bone marrow blasts and cytogenetic change) for subjects treated with siltuximab compared with the placebo group
    • To assess the safety profile of siltuximab and RBC transfusions among subjects with Low- or Intermediate-1 (INT-1)-risk MDS
    • To assess the pharmacodynamics, pharmacokinetics, and antibodies to siltuximab (immunogenicity) in MDS subjects
    •See protocol for additional objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)
    2. Confirmed diagnosis of MDS, according to WHO or FAB pathologic
    classification, with an IPSS score 0, 0.5, or 1.0, indicating Low- or INT-1-
    risk disease. Subjects with 5q- or PDGFR gene mutations are eligible if
    they are intolerant to or have failed prior specific therapy (eg,
    lenalidomide and imatinib mesylate).
    3. Documented RBC transfusion of at least 2 units of RBC for the
    treatment of the anemia of MDS in the 8 weeks preceding the start of the
    Screening Period.
    4. Adequate iron stores, demonstrated by either the presence of
    stainable iron in the bone marrow or a serum ferritin of > 100 ng/mL
    5. ECOG performance status score of 0 to 2
    6. Symptomatic anemia (defined by a score > 0 on the NCA-SS).
    7. Women of childbearing potential must agree to use adequate birth
    control measures during the study and for 3 months after receiving the
    last dose of study agent, and have a negative serum or urine beta human
    chorionic gonadotropin (beta hCG) pregnancy test at screening. Men
    must agree to use a double barrier method of birth control and to not
    donate sperm during the study and for 3 months after receiving the last
    dose of study agent
    8.Be willing and able to adhere to the prohibitions and restrictions
    specified in this protocol
    9.Sign (or their legally acceptable representatives must sign) an
    informed consent document indicating that they understand the purpose
    of and procedures required for the study and are willing to participate in
    the study.
    E.4Principal exclusion criteria
    1.Had treatment with ESAs, androgens, hypomethylating agents,
    immunomodulatory drugs (IMiDs), or other agents targeting IL-6 or its
    receptor within 4 weeks of randomization
    2.Any condition that, in the opinion of the investigator, would make
    participation not be in the best interest (eg, compromise the well-being)
    of the subject or that could prevent, limit, or confound the protocolspecified
    assessments (eg, has a history of clinically significant,
    uncontrolled disease of the pulmonary, cardiovascular, endocrine,
    neurologic, gastrointestinal, or genitourinary systems that is not
    attributable to MDS). Subjects with Chronic Myelomonocytic Leukemia
    (CMML) are to be excluded from the study.
    3.Causes other than MDS contributing to anemia, such as Vitamin B12 or
    folate deficiency, bleeding, hemolysis, hemoglobinopathy, or chronic
    renal failure
    4.Known unmanageable allergies, hypersensitivity, or intolerance to
    monoclonal antibodies or to murine, chimeric, or human proteins or their
    excipients
    5.A history of seropositivity for human immunodeficiency virus (HIV),
    hepatitis B virus (HBV), or hepatitis C virus (HCV) (Note: HBV antibodypositivity
    is not a reason for exclusion from the study)
    6.Received an investigational drug (including investigational vaccines)
    or used an invasive investigational medical device within 30 days or 5
    half lives before randomization or is currently enrolled in an
    investigational study
    7.Had a modification of an effective preexisting therapy for the explicit
    purpose of entering the study.
    8.Is a woman who is pregnant, or breast-feeding, or planning to become
    pregnant or is a man who plans to father a child while enrolled in this
    study or within 12 weeks after the last dose of study agent
    9.Had hospitalization for infection or major surgery, (eg, requiring
    general anesthesia) within 2 weeks before randomization or will not
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    have fully recovered from surgery.
    Note: subjects with planned surgical procedures to be conducted under
    local anesthesia may participate
    10.Been vaccinated with live, attenuated vaccines within 4 weeks of
    randomization
    11.Has clinically significant laboratory abnormalities:
    •Platelets < 20 x 109/L
    •Estimated glomerular filtration rate (eGFR) <=20 mL/min
    •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥
    2.5 x upper limit of normal (ULN)
    •Bilirubin > 2.5 x ULN
    •Alkaline phosphatase ≥ 3 x ULN
    12.Is an employee of the investigator or study site, with direct
    involvement in the proposed study or other studies under the direction
    of that investigator or study site, as well as family members of the
    employees or the investigator
    NOTE: Investigators should ensure that all study enrollment criteria
    have been met at screening. If a subject's status (including laboratory
    results) changes after screening but before the first dose of study agent
    is given such that they now meet an exclusion criterion, then they should
    be excluded from participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving a reduction in RBC transfusions
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 week period from week 5 to week 12
    E.5.2Secondary end point(s)
    1. Hemoglobin Assessment
    2. Bone Marrow Examination
    3. Anemia Symptom Assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Week 12
    2. At Week 13 and every 24 weeks during treatment
    3. Daily for 12 weeks, then monthly for remainder of treatment period
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Open; study will continue until death, unacceptable toxicity, withdraw consent, or clinical cutoff
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Australia
    Belgium
    Netherlands
    Russian Federation
    Spain
    Sweden
    United States
    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
    Clinical cut-off is 24 weeks after the last patient has been randomized.
    Study end is 36 weeks after the last patient has been randomized.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 75
    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)
    Investigator to discuss options with the patient.
    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 Decision2011-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-06
    P. End of Trial
    P.End of Trial StatusCompleted
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