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    Summary
    EudraCT Number:2004-002132-26
    Sponsor's Protocol Code Number:WA18230
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-002132-26
    A.3Full title of the trial
    A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of rhuMAb 2H7 (Ro 496-4913, PRO70769) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberWA18230
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 Limited
    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 Information not present in EudraCT
    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 namerhuMAb 2H7
    D.3.2Product code Ro 496-4913
    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.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    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 number20
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the safety and tolerability of escalating single intravenous doses of rhuMAb 2H7 in combination with methotrexate, in patients with moderate to severe RA who have an unsatisfactory clinical response (i.e., partial responders to MTX).
    E.2.2Secondary objectives of the trial
    – To evaluate the efficacy of rhuMAb 2H7 in combination with MTX in patients with moderate to severe RA at 24 weeks
    – To characterize the pharmacokinetics and pharmacodynamics of rhuMAb 2H7 by evaluation of the relationship between the dose of rhuMAb 2H7 and onset, extent and duration of B-cell depletion
    – To collect research samples for the evaluation potential biomarkers which may be predictive of response to rhuMAb 2H7 treatment
    – To evaluate the effect of infusion time on the safety of administration of rhuMAb 2H7.
    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:
    • Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
    • Aged 18–80 years
    Have active disease defined as:
    • Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA (see Study Procedures and Administrative Manual)
    • Positive serum rheumatoid factor (≥20 IU/L)
    • Current treatment for RA on an outpatient basis
    • At screening: C-reactive protein (CRP) ≥1.5 mg/dL (15 mg/L)
    Or
    erythrocyte sedimentation rate (ESR) ≥28 mm/hr
    • Swollen joint count of ≥8 (66 joint count) and tender joint count of ≥8 (68 joint count) at screening and randomization (see Study Procedures and Administrative Manual)
    Previous and current treatments:
    • Have failed treatment (because of lack of tolerability or efficacy) with at least one but no more than five DMARDs or biologics (other than MTX)
    • Current treatment with MTX at a dose of 10–25 mg weekly (p.o. or parenterally) for at least 12 weeks, with the last 4 weeks prior to screening at a stable dose
    • All DMARDs other than MTX should be withdrawn at least 4 weeks prior to randomization (8 weeks for etanercept, infliximab, adalimumab and leflunomide [after cholestyramine drug removal for leflunomide unless it was discontinued 12 weeks prior to treatment])
    • If receiving current treatment with corticosteroids, the dose must not exceed 10 mg/day prednisone or equivalent and the last 4 weeks prior to screening must be at a stable dose
    • If receiving current treatment with NSAIDs, the patient must be on stable dose for the last 2 weeks prior to screening
    • Patient must be willing to receive oral folic acid
    Other:
    • For patients of reproductive potential (males and females), a reliable means of contraception must be used (e.g., hormonal contraceptive, intrauterine device, physical barrier)
    • For females of childbearing potential (including those who have had a tubal ligation), a serum pregnancy test within 2 weeks prior to randomization must be negative.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria related to rheumatoid arthritis are ineligible for study entry:
    • Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
    • Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty’s syndrome); patients with Sjogren’s syndrome with RA are eligible.
    • Functional Class IV as defined by the ACR classification of functional status in RA (see Study Procedures and Administrative Manual)
    • History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome).

    Exclusion Criteria Related to Medications
    Patients who meet the following criteria related to medications will be excluded:
    • Concurrent treatment with any DMARD (except MTX) or any anti–TNF-α therapy or other biologic therapy
    • Treatment with any investigational agent within 4 weeks of screening or five half-lives of the investigational drug (whichever is longer)
    • Previous treatment with any cell-depleting therapies, including investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, or alefacept)
    • Previous treatment within 6 months with IV γ-globulin or Prosorba® column
    • Intra-articular or parenteral corticosteroids within 4 weeks prior to the screening visit
    • Receipt of a live/attenuated vaccine within 4 weeks prior to randomization
    • Previous treatment with rituximab (MabThera®/Rituxan®)

    Exclusion Criteria Related to General Safety
    The following are exclusions related to general safety:
    Allergies
    • History of severe allergic or anaphylactic reactions to humanized or chimeric monoclonal antibodies
    Infections
    • Known active bacterial, viral, fungal, mycobacterial, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
    • History of active tuberculosis (TB) or concurrent treatment for TB
    • Positive purified protein derivative (PPD) screening test (see Study Procedures and Administrative Manual for Centers for Disease Control guidelines and definition of high risk individuals)
    • History of recurrent significant infections
    Other
    • Primary or secondary immunodeficiency (history of or currently active)
    • Evidence of significant and/or uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine, or gastrointestinal disorders
    • History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been excised and resolved)
    • History of alcohol, drug, or chemical abuse within the 6 months prior to screening
    • Neuropathies and neurovasculopathies that might interfere with pain evaluation
    • Lack of peripheral venous access
    • Pregnancy or lactation

    Exclusion Criteria Related to Laboratory Findings at Screening
    Patients who meet the following criteria related to laboratory findings at screening will be excluded:
    • Serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men
    • Aspartate aminotransferase or alanine aminotransferase > 2.5 × the upper limit of normal
    • Platelet count < 100,000/μL
    • Hemoglobin < 8.5 g/dL
    • Neutrophils < 1.5 × 103/μL
    • Positive hepatitis B or C serology
    • Serum IgG and IgM levels below 5.65 and 0.55 mg/mL, respectively
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this study is the safety and tolerability of rhuMAb 2H7 in patients with moderate to severe RA.
    Safety will be assessed using the following measures:
    • Incidence of adverse events (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0)
    • Incidence of clinical laboratory abnormalities
    • Incidence of human anti rhuMAb 2H7 antibodies
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation study
    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.8.5The 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
    The end of the study is defined as completion of the Week 72 visit unless B-cells are still depleted when there is a safety follow-up for 48 weeks or until B-cells have returned to normal, whichever is the later.
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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 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 2005-12-07. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 160
    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 Decision2005-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-06
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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