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    Summary
    EudraCT Number:2006-005353-30
    Sponsor's Protocol Code Number:WA20497
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-28
    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 ConcernedLithuania - SMCA
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) FILM.
    A.3.2Name or abbreviated title of the trial where available
    FILM
    A.4.1Sponsor's protocol code numberWA20497
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00485589
    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 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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameocrelizumab
    D.3.2Product code RO 496-4913
    D.3.4Pharmaceutical form Concentrate 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 INNocrelizumab
    D.3.9.2Current sponsor codeRO 496-4913
    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) 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 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
    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 PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 efficacy of ocrelizumab versus placebo, when used in combination with methotrexate (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
    • To determine the efficacy of ocrelizumab versus placebo, in
    combination with methotrexate (MTX) in reducing signs and symptoms
    • To assess the safety of ocrelizumab versus placebo, in
    combination with MTX
    • To investigate the pharmacokinetics, immunogenicity and
    pharmacodynamic parameters of ocrelizumab
    • To explore the long-term efficacy and safety of further
    courses of ocrelizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women ≥18 years old, with active RA of at least 3 months and less than 5 years duration who are naive to methotrexate (MTX)

    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)
    24. Treatment with any investigational agent within 12 weeks or five half-lives of the investigational drug (whichever is longer) prior to baseline
    25. Previous treatment with any cell-depleting therapies, including investigational agents (e.g., CAMPATH, anti-CD3, anti-CD4, anti-CD5, anti-CD11a, anti-CD19, anti-CD22, anti-BLys/BAFF, and anti-CD20)
    26. Treatment with iv γ-globulin or Prosorba® column within 24 weeks prior to baseline
    27. Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
    28. Receipt of any vaccine within 6 weeks prior to baseline. It is recommended that a patient’s vaccination record and the need for immunization should be carefully reviewed prior to receiving ocrelizumab)
    29. Intolerance or contraindications to iv methylprednisolone

    Exclusions Related to Laboratory Values at Screening
    30. Positive urine pregnancy test
    31. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal
    32. Hypogammaglobulinemia (IgG <4 mg/mL, and/or IgM <0.55 mg/mL)
    33. Absolute neutrophil count <1500 cells/µL

    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 104 Weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    1. Health Assessments Questionnaire - Disability Index (HAQ-DI) score
    2. Proportion of patients with a major clinical response
    3. Proportion of patients achieving Disease Activity Score (DAS28) remission
    4. Change in DAS28 from baseline
    5. EULAR response rates
    6. Proportion of patients achieving an ACR20/ACR50/ACR70/ ACR90 response
    7. Proportion of patients with a reduction of at least 0.25 units in the HAQ-DI score from baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 104
    2. Weeks 52 and 104
    3. Weeks 24, 52, and 104
    4. Weeks 24, 52, and 104
    5. Weeks 24, 52, and 104
    6. Weeks 24, 52, and 104
    7. Weeks 24 and 52
    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.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.2.4Number 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 EEA38
    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
    Australia
    Brazil
    Israel
    Italy
    Korea, Republic of
    Lithuania
    Mexico
    New Zealand
    Panama
    Peru
    Philippines
    Poland
    Russian Federation
    South Africa
    Spain
    Switzerland
    Taiwan
    Thailand
    United Kingdom
    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
    Please refer to Section 3.1.4 in the Protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.2.1Number of subjects for this age range: 496
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 117
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 223
    F.4.2.2In the whole clinical trial 600
    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 Decision2007-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-29
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