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    Summary
    EudraCT Number:2011-005634-19
    Sponsor's Protocol Code Number:CD-IA-CAM-3001-1071
    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:2012-04-24
    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 number2011-005634-19
    A.3Full title of the trial
    A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.
    Estudio de fase 2b para evaluar la eficacia y seguridad de mavrilimumab en pacientes con artritis reumatoide moderada o grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.
    Estudio de fase 2b para evaluar la eficacia de mavrilimumab, un anticuerpo desarrollado para el tratamiento de la artritis reumatoide moderada o grave, una enfermedad inflamatoria que afecta a las articulaciones
    A.4.1Sponsor's protocol code numberCD-IA-CAM-3001-1071
    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 SponsorMedImmune Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportMedImmune Ltd
    B.4.2CountryUnited Kingdom
    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--
    B.5.3 Address:
    B.5.3.1Street Address--
    B.5.3.2Town/ city--
    B.5.3.3Post code--
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number--------
    B.5.5Fax number--------
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 namemavrilimumab
    D.3.2Product code CAM-3001
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmavrilimumab
    D.3.9.1CAS number 1085337-57-0
    D.3.9.2Current sponsor codeCAM-3001
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid arthritis
    Artritis Reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    Artritis Reumatoide
    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 evaluate the efficacy of mavrilimumab in subjects with moderate-to-severe adult onset RA.
    Evaluar la eficacia de mavrilimumab en pacientes con artritis reumatoide (AR) moderada o grave de inicio en la edad adulta
    E.2.2Secondary objectives of the trial
    To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.
    Evaluar la seguridad, tolerabilidad, farmacocinética , inmunogenicidad y otros resultados clinicos en AR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? A diagnosis of adult onset RA in line with the protocol
    ? Moderately active disease in line with the protocol
    ? A pre-defined number of swollen joints in line with the protocol
    ? Inadequate response to one or more conventional DMARDs
    ? No evidence of respiratory disease
    - Diagnóstico de AR de inicio en la edad adulta definida de acuerdo al protocolo
    - Enfermedad moderadamente activa de acuerdo al protocolo
    - Un numero predeterminado de articulaciones inflamadas en de acuerdo al protocolo
    - Respuesta inadecuada a uno o más FARME convencionales
    - Sin indicios de enfermedad respiratoria
    E.4Principal exclusion criteria
    ? A rheumatic autoimmune disease other than RA, or significant systemic extra-articular involvement
    secondary to RA
    ? A history of, or current, inflammatory joint disease other than RA
    ? Previous treatment with the investigational drug
    ? Discontinuation of a biologic DMARD due to lack of efficacy.
    ? Non-compliant concurrent medications
    ? Non-compliance with medical history criteria
    - Una enfermedad reumática autoinmune distinta de la AR o una afectación extraarticular sistémica significativa secundaria a la AR
    - Tener antecedentes o padecer en la actualidad una enfermedad articular inflamatoria aparte de la AR
    - Tratamiento previo con el medicamento en investigacion
    - Tratamiento previo con FARME biológicos interrumpido debido a la falta de eficacia
    - Medicacion concomitante no permitida
    - Incumplimiento de los criterios de la historia clinica
    E.5 End points
    E.5.1Primary end point(s)
    Change from Day 1 score at Week 12 (assessment 1) and Week 24 (assessment 2) in protocol-defined assessments of RA efficacy.
    Variación en la puntuación desde el día 1 (evaluación 1) a la semana 12 (evaluación 2) de acuerdo a las evaluaciones de eficacia de la AR en protocolo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 and Week 24.
    Semana 12 y Semana 24
    E.5.2Secondary end point(s)
    To evaluate the safety, tolerability, PK, IM and other clinical outcomes in RA.
    Evaluar la seguridad, tolerabilidad, farmacocinética, inmunogenicidad y otros resultados clinicos en AR
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified by the protocol (Table 5.1-1)
    Según lo especificado en el protocolo (Table 5.1-1)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 No
    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 EEA45
    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
    Bulgaria
    Chile
    Czech Republic
    Estonia
    France
    Germany
    Hungary
    Mexico
    Russian Federation
    Serbia
    South Africa
    Spain
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 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.1.2.1Number of subjects for this age range: 252
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 280
    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)
    None
    Ninguno
    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 Decision2012-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
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