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    Summary
    EudraCT Number:2006-005353-30
    Sponsor's Protocol Code Number:WA 20497
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-005353-30
    A.3Full title of the trial
    A randomized, double-blind, parallel group, international study to
    evaluate the safety and efficacy of ocrelizumab in combination
    with methotrexate (MTX) compared to MTX alone in
    methotrexate- naïve patients with active rheumatoid arthritis.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberWA 20497
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorROCHE
    B.1.3.4CountryItaly
    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 RO496-4913
    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.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO496-4913
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    To determine the efficacy of ocrelizumab versus placebo,
    when used in combination with MTX, to reduce or inhibit
    progression of joint damage in MTX-naïve patients.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of ocrelizumab to prevent disability in
    these patients.
    To determine the efficacy of ocrelizumab versus placebo, in
    combination with MTX in reducing signs and symptoms in
    these patients.
    To assess the safety of ocrelizumab versus placebo, in
    combination with MTX.
    To investigate the pharmacokinetics, immunogenicity and
    pharmacodynamic parameters of ocrelizumab in this patient
    population.
    To explore the long-term efficacy and safety of further
    courses of ocrelizumab.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    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. Have active disease defined as:
    a. Diagnosis of RA of at least 3 months and less than
    5 years duration using the ACR criteria for the
    classification of RA.
    b. Swollen joint count (SJC) >= 8 (66 joint count) and tender
    joint count (TJC) >= 8 (68 joint count) at screening and
    baseline.
    c. CRP >= 1.0 mg/dL using a high-sensitivity assay.
    d. Positive rheumatoid factor or positive anti-CCP antibody
    or both.
    4. Previous and current treatments:
    a. Patients naïve to and considered to be candidates for
    treatment with MTX.
    b. Patients who are to receive, or who are currently
    receiving treatment for RA on an outpatient basis.
    c. If receiving current treatment with corticosteroids, the
    dose must not exceed 10 mg/day prednisolone or
    equivalent and during the four weeks prior to baseline it
    must be at a stable dose.
    d. If receiving current treatment with NSAIDs, the patient
    must be on a stable dose for the 4 weeks prior to
    baseline.
    e. Patient must be willing to receive oral folic acid or
    equivalent.
    5. Other:
    a. 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.
    b. Female patients of childbearing age must have a negative
    urine pregnancy test.
    E.4Principal exclusion criteria
    Exclusion Criteria Related to Rheumatoid Arthritis
    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 Rheumatoid Arthritis (Appendix 3)
    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).
    Exclusions 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 breast feeding.
    8. Known significant cardiac disease (NYHA Class III and IV).
    9. Known severe chronic obstructive pulmonary disease
    (COPD; [FEV1 < 50% predicted or Functional dyspnoea
    >= Grade 3 on the MRC Dyspnoea Scale]).
    10. Evidence of significant uncontrolled concomitant diseases
    such as nervous system, renal, hepatic, endocrine, or
    gastrointestinal disorders which, in the investigator's opinion,
    would preclude patient participation.
    11. Any neurological (congenital or acquired), psychiatric,
    vascular or systemic disorder which could affect any of the
    efficacy assessments, in particular, joint pain and swelling
    (e.g. Parkinson's disease, cerebral palsy, diabetic neuropathy,
    chronic fatigue syndrome, chronic remitting anemia of
    unknown origin or requiring transfusion).
    12. Uncontrolled disease states where flares are commonly
    treated with oral or parenteral corticosteroids.
    13. Primary or secondary immunodeficiency (history of, or
    currently active), 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 iv anti-infectives
    within 4 weeks of baseline or oral anti-infectives within
    2 weeks prior to baseline.
    15. History of deep space/tissue infection (e.g. fasciitis, abscess,
    osteomyelitis, 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 haematologic 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. Prior receipt of any biologic therapy used for treatment of
    RA.
    23. Concurrent treatment with any DMARD. All DMARDs
    should be withdrawn at least 4 weeks prior to baseline
    (12 weeks for leflunomide or 4 weeks after 11 days of
    standard cholestyramine or activated charcoal drug removal).
    E.5 End points
    E.5.1Primary end point(s)
    The treatment difference in change from baseline of the modified total Sharp Score (TSS) at 52 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 No
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.2.3.1Comparator description
    combination with MTX vs MTX
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-07-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    presence of the legal representative
    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 223
    F.4.2.2In the whole clinical trial 600
    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 Decision2007-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-29
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