Clinical Trial Page

Summary
EudraCT Number:2010-021020-94
Sponsor's Protocol Code Number:ACT11575
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Prematurely Ended
Date on which this record was first entered in the EudraCT database:2010-10-21
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2010-021020-94
A.3Full title of the trial
Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________
A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled
study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists
A.3.2Name or abbreviated title of the trial where available
Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-?
A.4.1Sponsor's protocol code numberACT11575
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 SponsorSanofi-aventis Recherche & Développement
B.1.3.4CountryFrance
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.3.2Product code SAR153191
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2Current sponsor codeSAR153191
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number75
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 No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
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 SIMPONI 50 mg solución inyectable en pluma precargada
D.2.1.1.2Name of the Marketing Authorisation holderCENTOCOR B.V.
D.2.1.2Country which granted the Marketing AuthorisationSpain
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.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
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 INNGOLIMUMAB
D.3.9.3Other descriptive nameGOLIMUMAB
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) 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 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
artritis reumatoide activa
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 12.1
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
Demostrar que SAR153191, administrado junto con MTX, posee una eficacia superior a la de placebo en el alivio de signos y síntomas de la AR en pacientes con AR activa que no respondieron a un máximo de dos antagonistas del TNF-α
E.2.2Secondary objectives of the trial
Evaluar la seguridad de SAR153191
Documentar el perfil farmacocinético de SAR153191
E.2.3Trial contains a sub-study Yes
E.2.3.1Full title, date and version of each sub-study and their related objectives
Subestudio para el análisis farmacogenético, versión 2 de fecha 14/07/2010.
- Caracterizar la relación farmacocinética/farmacodinámica entre SAR153191 y biomarcadores elegidos como proteína C reactiva (PCR), interleucina sérica (IL)-6 y receptor de la interleucina-6 soluble (sIL-6R)
- Recoger ADN, ARN, suero y orina con el fin de investigar la detección de biomarcadores pronósticos.
E.3Principal inclusion criteria
- Diagnóstico de artritis reumatoide de duración superior o igual a 6 meses y estado funcional de clase I-III del American College of Rheumatology (ACR) en la selección y en el periodo basal
- Enfermedad activa, definida como:
1)al menos 6 de 68 articulaciones doloridas y 6 de 66 articulaciones inflamadas en la selección y el periodo basal y
2)hs-PCR superior a 10 mg/l en la selección O VSG superior a 28 mm/h
- Tratamiento continuo con MTX durante al menos 12 semanas antes de la selección y con una dosis estable (mínimo 10 mg/semana) durante al menos 6 semanas antes de la visita de selección
- Pacientes sin respuesta primaria a inhibidores del TNF-α (máximo 2 fármacos), definido para cada antagonista de TNF-α como:
1)Adecuado para el tratamiento, basándose en la falta de eficacia anterior de antirreumáticos modificadores de la enfermedad (DMARD) (como mínimo uno), incluido MTX, y actividad de la enfermedad (puntuación de la actividad de la enfermedad [DAS] > 2,4 o puntuación de la actividad de la enfermedad-28 [DAS28] > 3,2 O BIEN un mínimo de 8 articulaciones inflamadas O registros del médico indicativos de "enfermedad activa")
- Ausencia de respuesta clínica adecuada al tratamiento con inhibidores de TNF-α después de un mínimo de 3 meses, con tratamiento concomitante con MTX (7,5 a 25 mg/semana), sulfasalazina (3 a 4 g/día) o leflunomida (20 mg/día) conforme al menos uno de los siguientes criterios:
Ausencia de respuesta conforme a la European League Against Rheumatism (EULAR) (< 0,6 de mejoría en la puntuación DAS o DAS28)
< ACR20, (por índice de actividad de la enfermedad de la serie principal del ACR, si está disponible)
< 20% de mejoría respecto al periodo basal en el número de articulaciones doloridas (NAD), número de articulaciones inflamadas (NAI) (si la serie principal del ACR total está incompleta)
- Pacientes que han firmado un consentimiento informado por escrito antes de realizar cualquiera de los procedimientos relacionados con el estudio.
E.4Principal exclusion criteria
- Edad inferior a 18 años o superior 75 años.
- Mujeres en edad fértil que no desean utilizar un método anticonceptivo admitido o evitar quedarse embarazadas durante todo el estudio. Entre los métodos anticonceptivos admitidos se incluyen los anticonceptivos orales (uso continuado, por prescripción, de 2 o más ciclos antes de la selección) u otros métodos alternativos farmacológicos con receta o quirúrgicos como dispositivos intrauterinos; preservativos, esponja anticonceptiva o diafragma + espuma o gel; ligadura bilateral de trompas; o vasectomía; además, pacientes que no desean o son incapaces de ser sometidas a una prueba del embarazo.
- Fiebre (superior a 38ºC) de origen desconocido, crónica, persistente o infecciones recurrentes.
- Historia de enfermedad desmielizante
- Enfermedad hepatobiliar de base en el momento del inicio estudio.
E.5 End points
E.5.1Primary end point(s)
Mejoría del ACR20% (índice compuesto) de la tasa de respuesta a las 12 semanas (porcentaje de pacientes que lograron una mejoría del 20% respecto al periodo basal a las 12 semanas, evaluado conforme al índice de actividad de la enfermedad de la serie principal del American College of Rheumatology [ACR])
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 No
E.6.10Pharmacogenetic Yes
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic Yes
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) 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) Yes
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.8.4.1Number of sites anticipated in Member State concerned4
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA41
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 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
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 months2
E.8.9.1In the Member State concerned days14
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months2
E.8.9.2In all countries concerned by the trial days14
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 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 state8
F.4.2 For a multinational trial
F.4.2.1In the EEA 84
F.4.2.2In the whole clinical trial 250
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 Decision2010-12-21
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2010-12-13
P. End of Trial
P.End of Trial StatusPrematurely Ended
P.Date of the global end of the trial2011-05-20

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