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    Summary
    EudraCT Number:2008-004931-39
    Sponsor's Protocol Code Number:ALD518-CLIN-003
    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:2008-11-04
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2008-004931-39
    A.3Full title of the trial
    A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.
    A.4.1Sponsor's protocol code numberALD518-CLIN-003
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlder Biopharmaceuticals, 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameALD518
    D.3.2Product code ALD518
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeALD518
    D.3.9.3Other descriptive nameALD518 monoclonal antibody (anti IL-6 mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboIntravenous 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
    Active Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 two IV infusions of ALD518 80, 160, and 320 mg compared to two IV infusions of placebo in patients with active RA with an inadequate response to methotrexate.
    E.2.2Secondary objectives of the trial
    To determine the efficacy, PK, and immunogenicity of two IV infusions of ALD518 80, 160, and 320 mg compared to two IV infusions of placebo in patients with active RA with an inadequate response to methotrexate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be entered into this study only if they meet all of the following criteria:
    1. Are able to provide written informed consent
    2. Are aged between 18 and 80 years (inclusive)
    3. Have a diagnosis of active RA (ACR criteria 1987) at least 16 weeks before the Screening visit. (See Appendix I)
    4. Have an ACR global functional status class of 1 to 3. (See Appendix II)
    5. Have a minimum of 6 swollen and 6 tender joints on a 66/68 joint analysis at screening and pre-dose
    6. Have a CRP of ≥ 10 mg/L
    7. Have been on a stable dose of methotrexate (≥ 10 mg/week) for at least 3 months before study Day 1. (Patients must take their methotrexate during the study at a stable dose.)
    8. Stable optional RA medication:
    • Folic acid supplementation if already in use
    • Non steroidal anti-inflammatory drugs (NSAIDs) including cyclooxengase 2 (Cox 2) inhibitors – doses must be stable for 4 weeks before Day 1 and consistent with labeling recommendations.
    • Acetylsalicylic acid is allowed in low doses (e.g., ≤ 100 mg/day) as cardiovascular prophylaxis.
    • Oral glucocorticoids, daily doses of ≤ 10 mg/day of prednisolone or equivalent for 4 weeks before Day 1
    • Painkillers (acetaminophen, Tramadol and similar, alone or in combinations) usage as per routine instructions will be allowed, except for 24 hours before rheumatology evaluations
    9. Are not pregnant and do not plan to become pregnant during the study. Females of childbearing potential must provide a negative pregnancy test within the Screening period and must be using adequate contraception (oral or injectable [depot] oestrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method [e.g., condom and diaphragm or spermicidal gel]). Non childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start.
    E.4Principal exclusion criteria
    Patients will be entered into this study only if they meet none of the following criteria:
    1. Arthritis onset prior to 16 years old
    2. Ongoing systemic inflammatory condition which may interfere with the results of clinical or laboratory tests planned in the study (eg, systemic lupus erythematosus or any other systemic rheumatic disease other than RA)
    3. Have been on any biological therapy in previous 12 months (before Day 1) or has had any evidence of immunogenicity during previous biological therapy
    4. Have a previous history of tuberculosis
    5. Have a positive tuberculin skin test at Screening (indicative of active tuberculosis infection)
    6. Have a current or recent (last 3 months) serious infection (requiring treatment with parenteral antibiotics)
    7. Have received treatment with any other investigational drug in the last 12 months (before Day 1)
    8. Have participated in an investigational study within the last 30 days (before signing of the informed consent) or expect to be treated with an investigational product during this study period
    9. Have severe disease likely to jeopardize the planned completion of the study (e.g., recent myocardial infarction, unstable angina pectoris, uncontrolled diabetes mellitus)
    10. Have any clinically significant concurrent medical condition as shown by, but not limited to:
    Hepatic
    • ALT ≥ 3 x ULN
    • AST ≥ 3 x ULN
    Hematology
    • Hemoglobin < 9 g/dL
    • Absolute neutrophil count < 1.5 x 109/L
    • Platelets < 100 x 109/L
    11. Have present or previous malignancies, except history of cured squamous or basal skin cell carcinoma or cured breast or cervical cancer for ≥ 10 years without evidence of recurrence
    12. Require one or several of the following medications:
    • Narcotics or any drug for treatment of RA other than:
    • NSAIDs
    • Cox-2 inhibitors
    • Acetaminophen/paracetamol for pain and arthritis control
    • Tramadol
    • Low dose aspirin (except for cardiovascular prophylaxis)
    • Use of disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate, within 4 months before Day 1
    • Intra-articular, intramuscular, or intravenous glucocorticoids within 4 weeks before Day 1.
    13. Have any clinically significant abnormality on physical examination, laboratory testing, vital signs, or 12-lead ECG suggestive of a significant unstable medical condition
    14. Are pregnant or a nursing mother
    15. Have a history of (within 12 months of Screening), or known current problems with drug or alcohol abuse
    16. Have a history or suspicion of unreliability, poor cooperation, or non compliance with medical treatment
    17. Have any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are changes in safety as follows:
    • Incidence and severity of AEs and SAEs during the study
    • Changes in vital signs and 12 lead ECG during the study
    • Changes in physical examination during the study
    • Changes in anti nuclear antibody (ANA) and anti dsDNA during the study
    • Changes in laboratory assessments (serum chemistry, hematology and urinalysis) during the study.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months7
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 120
    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 Decision2008-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-17
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