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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2015-002634-41
    Sponsor's Protocol Code Number:1297.3
    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:2015-10-30
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-002634-41
    A.3Full title of the trial
    Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab
    Evaluación a largo plazo de la seguridad, la eficacia, la farmacocinética y la inmunogenicidad de BI 695501 en pacientes con artritis reumatoide (AR): ensayo de extensión abierto para pacientes que hayan terminado el ensayo 1297.2 y sean aptos para un tratamiento a largo plazo con adalimumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term study of BI695501 in patients with active rheumatoid arthritis
    Ensayo de extensión abierto a largo plazo de BI 695501 en pacientes con artritis reumatoide
    A.4.1Sponsor's protocol code number1297.3
    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 SponsorBoehringer Ingelheim International GmbH
    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 supportBoehringer Ingelheim International GmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.4Telephone number+34934045100
    B.5.5Fax number+34934045580
    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 BI 695501
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeBI 695501
    D.3.9.3Other descriptive nameBI 695501
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. medicinal product typeMonoclonal antibody Anticuerpo monoclonal
    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
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Artritis reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    The objective of this trial is to provide long-term safety, efficacy, PK, and immunogenicity data on BI 695501 administered via prefilled syringe in patients with RA who have completed Trial 1297.2 (EudraCT no. 2012-002945-40).
    El objetivo de este ensayo consiste en proporcionar datos sobre la seguridad, la eficacia, la farmacocinética (FC) y la inmunogenicidad a largo plazo de BI 695501 administrado mediante una jeringuilla precargada en pacientes con AR que hayan terminado el ensayo 1297.2 (EudraCT no. 2012-002945-40).
    E.2.2Secondary objectives of the trial
    Long-term efficacy will be assessed as a secondary objective in this trial.
    La eficacia a largo plazo se evaluará como objetivo secundario en este ensayo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All patients must sign and date an Informed Consent Form consistent with ICH GCP guidelines and local legislation prior to participation in the trial (i.e., prior to any trial procedures, which include medication washout and restrictions) and be willing to follow the protocol.
    2. Adult patients with moderately to severely active RA who have completed Trial 1297.2, and who wish to participate in this extension trial and in the Investigator?s assessment can benefit from receiving BI 695501.
    3. Patients willing and able to self-administer BI 695501 pre-filled syringe.
    4. For participants of reproductive potential (males and females), a reliable means of contraception has to be used throughout trial participation. Acceptable methods of birth control include, for example, birth control pills, intrauterine devices, surgical sterilization, vasectomized partner and double barrier method (for example male condom in combination with female diaphragm/cervical cap plus spermicidal foam/gel/film/cream/suppository). All patients (males and females of child-bearing potential) must also agree to use an acceptable method of contraception for 6 months following completion or discontinuation from the trial medication.
    1. Antes de participar en el ensayo (es decir, antes de la realización de cualquier procedimiento del ensayo, incluido el reposo farmacológico y cualquier restricción de medicación), todos los pacientes deberán mostrarse dispuestos a seguir el protocolo y a firmar y fechar un formulario de consentimiento informado que cumpla con las directrices de BPC de la ICH y la legislación local.
    2. Pacientes adultos con AR activa de moderada a grave que hayan terminado el ensayo 1297.2, que deseen participar en este ensayo de extensión y que, según la evaluación del investigador, se puedan beneficiar si reciben BI 695501.
    3. Pacientes dispuestos y capaces de autoadministrarse BI 695501 con una jeringuilla precargada.
    4. Los participantes en edad fértil (hombres y mujeres) deberán utilizar un método anticonceptivo fiable durante toda su participación en el ensayo. Los métodos anticonceptivos admisibles son, por ejemplo, píldoras anticonceptivas, dispositivos intrauterinos, esterilización quirúrgica, pareja vasectomizada y método de doble barrera (por ejemplo, una combinación de preservativo masculino con diafragma o capuchón cervical femenino más espuma, gel, película, crema o supositorio espermicidas). Todos los pacientes (hombres y mujeres en edad fértil*) también deberán comprometerse a utilizar un método anticonceptivo aceptable durante 6 meses tras la finalización o la interrupción de la medicación del ensayo.
    E.4Principal exclusion criteria
    1. Patients who experienced Investigator-reported drug-related serious adverse events (SAEs) in Trial 1297.2.
    2. Patients with major protocol deviations in Trial 1297.2.
    3. ACR functional Class IV or wheelchair/bed bound.
    4. Primary or secondary immunodeficiency (history of, or currently active).
    5. Positive QuantiFERON test.
    6. Known clinically significant coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (New York Heart Association Classes III or IV), or interstitial lung disease observed on chest X-ray.
    7. Anaphylactic reaction or hypersensitivity to adalimumab received in Trial 1297.2.
    8. History or recent evidence of cancer including solid tumors, hematologic malignancies, and carcinoma in situ (except participants with previous resected and cured basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ Grade I cervical cancer within 5 years prior to the Screening Visit).
    9. Positive serology for HBV or hepatitis C virus (HCV).
    10. Patients who are expecting to receive any live virus or bacterial vaccinations during the trial, or up to 3 months after the last dose of trial drug.
    11. Any treatment (including biologic therapies) that, in the opinion of the Investigator, may place the patient at unacceptable risk during the trial.
    12. Patients with a significant disease other than RA and/or a significant uncontrolled disease
    13. Premenopausal (last menstruation 1 year prior to screening), sexually active women who are pregnant or nursing, or are of child-bearing potential and not practicing an acceptable method of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial (acceptable methods of birth control are intrauterine
    devices, surgical sterilization, double barrier, or vasectomized partner).
    14. 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, pulmonary fibrosis, or Felty?s syndrome, scleroderma, inflammatory myopathy, mixed connective tissue disease, or any overlap syndrome). Secondary Sjögren?s syndrome or secondary limited cutaneous vasculitis with RA is permitted.
    15. Any planned surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) for the duration of the trial.
    16. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (i.v.) anti-infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit.
    17. Serious infection or opportunistic infection during the 1297.2 trial.
    18. Any acquired neurological, vascular, systemic or demyelinating disorder that might affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson?s disease, cerebral palsy, diabetic neuropathy) that occurred during the 1297.2 trial.
    19. Currently active alcohol or drug abuse.
    20. Treatment with i.v. Gamma Globulin or the Prosorba® Column during the 1297.2 trial.
    21. Planned treatment with i.v. intramuscular, intra-articular and parenteral corticosteroids.
    22. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times upper
    limit of normal (ULN).
    23. Hemoglobin <8.0 g/dL.
    24. Platelets <100,000/?L.
    25. Leukocyte count <4000/?L.
    26. Creatinine clearance <60 mL/min.
    27. Patients who are currently participating in another clinical trial other than Trial 1297.2.
    1. Pacientes que hayan experimentado acontecimientos adversos graves (AAG) relacionados con el fármaco descritos por el investigador durante el ensayo 1297.2.
    2. Pacientes que hayan tenido desviaciones importantes con respecto al protocolo en el ensayo 1297.2.
    3. Pacientes con clase funcional IV del ACR, en silla de ruedas o postrados en cama.
    4. Inmunodeficiencia primaria o secundaria (antecedentes o activa en la actualidad).
    5. Resultado positivo en la prueba QuantiFERON.
    6. Conocimiento de arteriopatía coronaria clínicamente significativa o arritmias cardíacas significativas o insuficiencia cardíaca congestiva grave (clases III o IV de la New York Heart Association), o neumopatía intersticial vista mediante radiografía.
    7. Reacción anafiláctica o hipersensibilidad a adalimumab recibido en el ensayo 1297.2.
    8. Antecedentes o indicios recientes de cáncer, incluidos tumores sólidos, neoplasias malignas hematológicas y carcinoma in situ (salvo los participantes con carcinoma basocelular o espinocelular previo resecado o curado, displasia de cuello uterino tratada o cáncer de cuello uterino in situ de grado I tratado durante los 5 años previos a la visita de selección).
    9. Serología positiva para el VHB o el virus de la hepatitis C (VHC).
    10. Pacientes que tengan previsto someterse a vacunas con virus o bacterias vivos durante el ensayo o hasta 3 meses después de la última dosis del fármaco del ensayo.
    11. Cualquier tratamiento (incluidos los biológicos) que, según el investigador, puedan suponer un riesgo inaceptable para el paciente durante el ensayo.
    12. Pacientes con una enfermedad importante distinta de la AR o una enfermedad importante no controlada (como, entre otros, trastornos del sistema nervioso, renales, hepáticos, endocrinos o gastrointestinales). Se define como enfermedad importante toda aquella que, según el investigador, pueda (i) suponer un riesgo para el paciente debido a su participación en el ensayo, (ii) influir en los resultados del ensayo, o (iii) suponer un motivo de preocupación con respecto a la capacidad del paciente para participar en el ensayo.
    13. Mujeres premenopáusicas (última menstruación 1 año antes de la selección); mujeres sexualmente activas en período de gestación o lactancia; o mujeres en edad fértil que no estén utilizando un método anticonceptivo aceptable o que no pretendan continuar utilizando un método anticonceptivo aceptable durante el ensayo (los métodos anticonceptivos aceptables son los dispositivos intrauterinos, la esterilización quirúrgica, la doble barrera o la vasectomía de la pareja).
    14. Artropatía inflamatoria en curso distinta de la AR (p. ej., gota, artritis reactiva, artritis psoriásica, espondiloartropatía seronegativa, enfermedad de Lyme) u otra enfermedad autoinmunitaria sistémica (p. ej., lupus eritematoso sistémico, enteropatía inflamatoria, fibrosis pulmonar, síndrome de Felty, esclerodermia, miopatía inflamatoria, enfermedad mixta del tejido conjuntivo o cualquier síndrome de solapamiento). Se permite el síndrome de Sjögren secundario o la vasculitis cutánea limitada secundaria con la AR.
    15. No se permite ninguna intervención quirúrgica prevista, incluidas las intervenciones quirúrgicas óseas, articulares y las sinoviectomías (incluidas la artrodesis o la sustitución articular) durante el transcurso del ensayo.
    16. Infección activa conocida de cualquier tipo (excepto infecciones micóticas del lecho ungueal) o cualquier episodio infeccioso grave que requiera hospitalización o tratamiento con antiinfecciosos intravenosos (IV) en un plazo de 4 semanas antes de la visita de selección o el tratamiento con antiinfecciosos orales en un período de 2 semanas antes de la visita de selección.
    17. Infección grave u oportunista durante el ensayo 1297.2.
    18. Cualquier trastorno neurológico, vascular, sistémico o desmielinizante adquirido que pueda afectar a cualquiera de las evaluaciones de la eficacia, en particular al dolor y la inflamación articulares (p. ej., enfermedad de Parkinson, parálisis cerebral, neuropatía diabética) producidos durante el ensayo 1297.2.
    19. Alcoholismo o toxicomanía activos en curso.
    20. Tratamiento con gammaglobulina IV o columna Prosorba® durante el ensayo 1297.2.
    21. Previsión de tratamiento con corticosteroides IV, intramusculares, intraarticulares y parenterales.
    22. Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 1,5 veces el límite superior de la normalidad (LSN).
    23. Hemoglobina < 8,0 g/dl.
    24. Plaquetas < 100 000/?l.
    25. Recuento de leucocitos < 4000/?l.
    26. Aclaramiento de creatinina < 60 ml/min.
    27. Pacientes que actualmente estén participando en otro ensayo clínico distinto del 1297.2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number (proportion) of patients with drug-related AEs (Adverse Events) during the treatment phase
    El criterio de valoración principal de este ensayo se define como el número (la proporción) de pacientes con acontecimientos adversos (AA) relacionados con el fármaco durante la fase de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint of this trial will be evaluated during the treatment phase of 48 Weeks. All AEs with an onset date between start of treatment and end of the REP (Residual effect period, after the last dose of medication with measureable drug levels or pharmacodynamic effects still likely to be present), a period of 10 weeks after the last dose of trial medication, will be assigned to the treatment phase for evaluation.
    El criterio de valoración primario de este ensayo se evaluará durante la fase de tratamiento de 48 semanas. Todos los acontecimientos adversos con una fecha de inicio entre el inicio del tratamiento y al final del REP (período de efecto residual, después de la última dosis de la medicación con los niveles de fármaco medibles o efectos farmacodinámicos todavía susceptibles de estar presentes), un período de 10 semanas después de la última dosis de medicación del ensayo, se asignará a la fase de tratamiento para la evaluación.
    E.5.2Secondary end point(s)
    Long-term efficacy will be assessed as a secondary objective in this trial:
    - The change from Baseline in DAS28 (ESR)
    - The proportion of patients meeting ACR20 response criteria
    - The proportion of patients who meet the ACR/European League Against Rheumatism (EULAR) definition of remission
    - The proportion of patients with EULAR response (good response, moderate response, or no response)
    La eficacia a largo plazo se evaluará como objetivo secundario en este ensayo.
    -El cambio desde el inicio en la puntuación DAS28 (VSG)
    - La proporción de pacientes que cumpla los criterios de respuesta ACR20
    - La proporción de pacientes que cumplan la definición de remisión del ACR/Liga Europea contra el Reumatismo (EULAR)
    - La proporción de pacientes con respuesta EULAR (respuesta buena, respuesta moderada o no respuesta)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. 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 No
    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.8.2.4Number of treatment arms in the trial1
    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 EEA37
    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
    Korea, Republic of
    Russian Federation
    United States
    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 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: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 178
    F.4.2.2In the whole clinical trial 400
    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)
    At the conclusion of the trial, the study drug will not be available and the care patients receive after the study will involve a different drug or treatment that the study doctor (in consultation with the hospital, if applicable) will consider the most suitable alternative.
    Al concluir el ensayo, el fármaco del estudio no estará disponible y la atención que reciban los pacientes despues del estudio implicará un medicamento o un tratamiento diferente que el médico del estudio (en consulta con el hospital, si aplica) considerará la alternativa más adecuada.
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-01
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