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    Summary
    EudraCT Number:2007-005759-41
    Sponsor's Protocol Code Number:WA20496
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-02-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-005759-41
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy
    A.4.1Sponsor's protocol code numberWA20496
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 nameocrelizumab
    D.3.2Product code RO 496-4913/F03
    D.3.4Pharmaceutical form Concentrate for solution for 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.3.8INN - Proposed INNocrelizumab
    D.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO 496-4913/F03
    D.3.9.3Other descriptive nameRhuMAb 2H7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    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 placeboConcentrate 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
    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
    Primary Objectives
    The primary objective of this study is to determine the efficacy and safety of 400 mg ocrelizumab, given as a single infusion, versus placebo, in combination with MTX, to reduce the signs and symptoms of RA at 24 weeks in patients with active RA who
    currently have an inadequate response to MTX therapy.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    Secondary objectives for this study are as follows:
    • To investigate and compare the pharmacokinetics and pharmacodynamics of a single and a dual infusion of ocrelizumab in this patient population
    • To assess the effect of a single infusion of ocrelizumab versus placebo on physical function in this patient population
    • To compare the safety and efficacy of single versus dual
    infusion at 24 and 48 weeks
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker project (optional):
    Samples will be used for research purposes to identify biomarkers that help understand differences in RA disease process and/or ocrelizumab treatment response, in accordance with the Sponsor biomarker strategy. These may include measurement of cytokines and other inflammatory proteins in plasma, as well as
    analysis of peripheral blood gene expression patterns in the context of disease, drug
    response, and toxicity.

    DNA sample collection:
    respond to treatment, those most susceptible to adverse events and those most likely to suffer disease progression and to identify genetic risk factors for the underlying disease.
    Several genetic pathways have been shown to be linked to the development of RA and to response to specific treatments . DNA will be collected in this study under two
    analysis categories: 1) clinical genotyping, to interrogate for specific genetic markers,
    and 2) pharmacogenomics, to enable whole genome association analysis for novel genetic markers that segregate with treatment response.
    E.3Principal inclusion criteria
    Patients must meet the following criteria to be eligible for study
    entry:
    1. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
    2. Age ≥ 18 years
    3. Current treatment for RA on an outpatient basis
    4. Active disease, defined as the following:
    a. A diagnosis of RA using the American College of Rheumatology (ACR) criteria for RA.
    b. Swollen joint count (SJC) ≥ 4 (66 joint count) and tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
    c. C-reactive protein (CRP) ≥ 0.6 mg/dL using a high-sensitivity assay or erythrocyte
    sedimentation rate (ESR) ≥ 28 mm/hour
    d. Positive rheumatoid factor or positive anti-cyclic citrullinated peptide (CCP) antibody, or both
    5. Inadequate clinical response to MTX taken at a dose of 7.5-25 mg/week for at least 12 weeks, with the last 4 weeks prior to baseline at a stable dose
    6. The patient must be willing to receive oral folic acid or equivalent.
    Previous and current treatments (beyond MTX) may include the following:
    7. If the patient is receiving current treatment with corticosteroids, the dose must not exceed 10 mg/day of prednisolone or equivalent, and, during the 4 weeks prior to baseline, it must be at a stable dose and remain stable for the duration of the study.
    8. If the patient is receiving current treatment with NSAIDs, the patient must be on a stable dose for the 4 weeks prior to baseline and remain stable for the duration of the study.
    9. May have experienced an inadequate response to previous or current treatment with other DMARDs and biologics such as etanercept, infliximab, adalimumab, or abatacept because of toxicity or inadequate efficacy.
    10. For patients of reproductive potential (males and females), a reliable means of contraception must be used for the duration of the study (e.g., hormonal contraceptive, intrauterine device, physical barrier) according to local guidelines.
    11. Female patients of childbearing age must have a negative urine pregnancy test.
    E.4Principal exclusion criteria
    Exclusion criteria related to RA:
    1. Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including, but not limited to, vasculitis, pulmonary fibrosis, or Felty’s
    syndrome). Patients with secondary Sjögren’s syndrome or secondary limited cutaneous vasculitis with RA are eligible.
    2. Functional Class IV as defined by the ACR Classification of Functional Status in RA.
    3. History of, or current, inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g. systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome)
    Exclusion criteria related to general health:
    4. Any surgical procedure, including bone or joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to or planned within 48 weeks after baseline.
    5. Sepsis in a prosthetic joint within the last 48 weeks or indefinitely if the prosthesis concerned remains in situ
    6. Lack of peripheral venous access
    7. Pregnancy or lactation
    8. Known significant cardiac disease (New York Heart Association [NYHA] Class III and IV).
    9. Known severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second [FEV1] < 50% predicted or functional dyspnea Grade≥ 3 on
    the Medical Research Council [MRC] Dyspnea Scale).
    10. Evidence of significant uncontrolled concomitant diseases
    11. Any neurological (congenital or acquired), psychiatric, vascular, or systemic disorder that could affect any of the efficacy assessments; in particular, joint pain and swelling
    12. Uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids
    13. History of, or currently active, primary or secondary immunodeficiency including known history of HIV infection
    14. Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV)
    anti-infectives within 4 weeks prior to baseline or oral anti-infectives within 2 weeks prior to baseline
    15. History of deep space/tissue infection (e.g., fasciitis, abscess, osteomyelitis, or septic arthritis of a native joint) within 48 weeks of baseline
    16. Evidence of chronic active hepatitis B or C
    17. Evidence of active tuberculosis. Patients receiving chemoprophylaxis for latent tuberculosis infection are eligible for the study
    18. History of serious recurrent or chronic infections not specified above
    19. History of cancer within the last 10 years, including solid tumors and hematologic malignancies and carcinoma in situ (except basal-cell and squamous-cell carcinomas of the skin or carcinoma in situ of the cervix uteri that have been excised and cured)
    20. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline
    Exclusion criteria related to medications:
    21. History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of ocrelizumab infusion
    22. Concurrent treatment with any DMARD except MTX. All DMARDs except MTX should be withdrawn at least 4 weeks prior to baseline (8 weeks for infliximab,
    adalimumab, or abatacept; 4 weeks for etanercept; and 12 weeks for leflunomide or 4 weeks after 11 days of standard cholestyramine or activated charcoal drug
    removal)
    23. Treatment with any investigational agent 12 weeks prior to baseline or five half-lives of the investigational drug prior to baseline, whichever is longer
    24. Previous treatment with any cell-depleting therapies, including investigational agents (e.g., alemtuzumab, anti-CD3, anti-CD4, anti-CD5, anti-CD11a, anti-CD19, anti-CD22, anti-BLys/BAFF, or anti-CD20)
    25. Treatment with IV γ-globulin or Prosorba® column (apheresis) within 24 weeks prior to baseline
    26. Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
    27. Receipt of any vaccine within 6 weeks prior to baseline. It is recommended that a patient’s vaccination record and the need for immunization prior to receiving ocrelizumab should be carefully reviewed prior to entry in the study
    28. Intolerance or contraindications to IV methylprednisolone.
    Exclusion criteria related to laboratory values at screening:
    29. Positive urine pregnancy test
    30. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN)
    31. Hypogammaglobulinemia (i.e., IgG < 4 mg/mL and/or IgM< 0.4 mg/mL)
    32. Absolute neutrophil count < 1500 cells/μL
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the proportion of patients with ACR20 responses at 24 weeks.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    QOL
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Please refer to Section 3.1.6 in the Protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 300
    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)
    Standard of Care
    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 Decision2008-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-19
    P. End of Trial
    P.End of Trial StatusOngoing
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