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    Summary
    EudraCT Number:2006-001000-37
    Sponsor's Protocol Code Number:ML19070
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-16
    Trial 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 ConcernedGermany - PEI
    A.2EudraCT number2006-001000-37
    A.3Full title of the trial
    Efficacy and safety of rituximab in patients with rheumatoid arthritis
    A.3.2Name or abbreviated title of the trial where available
    FIRST
    A.4.1Sponsor's protocol code numberML19070
    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 Pharma AG
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMabThera
    D.3.2Product code Ro 45-2294
    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 INNRituximab
    D.3.9.1CAS number 174722-31
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typegenetically engineered chimeric mouse/human monoclonal antibody
    D.8 Information on Placebo
    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 8.1
    E.1.2Level PT
    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 compare the efficacy of rituximab in rheumatoid arthritis after inadequate response to a single TNF-alpha inhibitors
    E.2.2Secondary objectives of the trial
    To demonstrate that treatment with rituximab in rheumatoid arthritis is safe
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age 18 to 80
    •Active rheumatoid arthritis (DAS 28 ≥3.2)
    •SJC ≥4 at screening and baseline
    •TJC ≥4 at screening and baseline
    •Patients with rheumatoid arthritis for at least 6 month diagnosed according to the revised 1987 ACR criteria for the classification of rheumatoid arthritis
    •Not more than one TNF╬▒- inhibitor in history
    •Inadequate response to either etanercept (Enbrel) or infliximab (Remicade) or adalimumab (Humira). Inadequate response is defined as either a lack of response to the respective drug or loss of response to the respective drug or intolerance to the respective drug. Etanercept treatment must have been stopped at least 4 weeks prior to first rituximab infusion, treatment with infliximab or adalimumab at least 8 weeks prior to first rituximab in-fusion.
    •Willingness and capability to give written informed consent, written consent for data protection (legal requirement in Germany: datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study.
    E.4Principal exclusion criteria
    Exclusion criteria related to RA
    •Functional class IV as defined by the ACR classification of Functional Status in Rheuma-toid Arthritis.
    Exclusion criteria related to general health conditions
    •Patients with other chronic inflammatory articular disease or systemic autoimmune dis-ease, e.g. Systemic lupus erythematosus, Sjögren’s syndrome, active rheumatoid vascu-litis, a history of systemic diseases associated with arthritis, chronic fatigue syndrome
    •Any active infection, a history of recurrent clinically significant infection, a history of re-current bacterial infections with encapsulated organisms
    •Primary or secondary immunodeficiency
    •History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
    •Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
    •Neuropathy that can interfere with quality of life and/or pain assessment.
    •Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
    •Known hypersensitivity to any component of the product or to murine proteins.
    •Women, pregnant, nursing or of childbearing potential with a positive pregnancy test (urine test)
    •Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier) for up to 12.5 months after first infusion of ri-tuximab
    •History of alcohol, drug or chemical abuse within 6 month prior to screening
    •Lack of peripheral venous access
    Exclusion criteria related to medications
    •Previous treatment with rituximab or intolerance to rituximab
    •Previous treatment with abatacept
    •Corticosteroids at doses exceeding 10 mg per day of prednisolone or the equivalent within the last 2 weeks prior to the first rituximab infusion or corticosteroids at instable doses within the last 2 weeks prior to the first rituximab infusion
    •Intolerance or contraindication to drugs required for the treatment of the side effects of ri-tuximab (e.g. paracetamol, acetaminophen, diphenhydramine, p.o. and i.v. corticosteroids, anti-emetics or H1 blockers)
    •Concurrent treatment with any DMARD (apart from MTX), any TNFalpha inhibitor, or any anti-IL or CTLA4 Ig or other biologic or any investigational agent
    •Receipt of a live vaccine within 4 weeks prior to treatment
    •Intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit
    Exclusion criteria related to lab findings
    •Haemoglobin < 8.5 g/dl
    •Neutrophil counts < 1.500 / µl
    •Platelet count < 75.000 / µl
    •Lower than 1 x 700/µl lymphopenia for more than three months prior to inclusion.
    •Serum creatinine > 1.4 mg/dl for women or 1.6 mg/dl for men.
    •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal.
    •Positive HIV or hepatitis C serology as well as positive tests for hepatitis B surface antigen (HBsAg) and/or positive tests for hapatitis B core antibody (HbcAb)).
    Exclusion criteria related to formal aspects.
    •Patients who have paritcipated in this study before.
    •Patients who participate currently in another clinical trial or patients who participated in another clinical trial during the last 30 days.
    •Patients who are underage or patients who are incapable to understand the aim, impor-tance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).
    •Patients who possibly are dependent on the sponsor or investigator.
    E.5 End points
    E.5.1Primary end point(s)
    change of DAS28 at week 24
    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 No
    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 No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned73
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 state300
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 300
    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 Decision2006-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-18
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