Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   43207   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    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) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-002306-31
    Sponsor's Protocol Code Number:M16-763
    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:2019-04-12
    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 number2018-002306-31
    A.3Full title of the trial
    A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)
    Estudio de extensión a largo plazo, en fase 2, multicéntrico, doble ciego y de grupos paralelos en pacientes con artritis reumatoide que han completado un ensayo en fase 2, aleatorizado y controlado precedente con ABBV-105 administrado solo o en combinación con upadacitinib (ABBV-599)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.
    Estudio fase 2 de extensión a largo plazo en pacientes con artritis reumatoide que han sido tratados anteriormente en un estudio previo con ABBV-105 dado solo o en combinación con upadacitinib.
    A.4.1Sponsor's protocol code numberM16-763
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    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 supportAbbVie INC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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.3.2Product code ABBV-105
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABBV-105
    D.3.9.1CAS number 1643570-24-4
    D.3.9.2Current sponsor codeABBV-105
    D.3.9.3Other descriptive nameABBV-105
    D.3.9.4EV Substance CodeSUB192702
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 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 ABBV-105
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABBV-105
    D.3.9.1CAS number 1643570-24-4
    D.3.9.2Current sponsor codeABBV-105
    D.3.9.3Other descriptive nameABBV-105
    D.3.9.4EV Substance CodeSUB192702
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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: 3
    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 nameUpadacitinib
    D.3.2Product code ABT-494
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUpadacitinib
    D.3.9.1CAS number 1310726-60-3
    D.3.9.2Current sponsor codeABT-494
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral 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
    Disease whereby the inflammation and swelling affects the joints
    resulting in pain
    Enfermedad en la cual la inflamación e hinchazón afectan a las articulaciones causando dolor.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 100000004870
    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 long-term safety, tolerability, and efficacy of ABBV-105 and ABBV-599 in RA subjects who have completed Study M16-063.
    El objetivo primario de este estudio es evaluar la seguridad a largo plazo, tolerabilidad, y eficacia de ABBV-105 y ABBV-599 en pacientes con aAR que han completado el estudio M16-063.
    E.2.2Secondary objectives of the trial
    n/a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult male or female, at least 18 years old.

    Diagnosis of RA for ≥ 3 months based on the 2010 ACR/EULAR classification criteria for RA.

    Females must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.

    For all females of child-bearing potential: a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug in the M16-063 study as well as persistently negative urine pregnancy test throughout M16-063 and at entrance into this study.

    Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control that is effective from Study Day 1 through at least 30 days. If required per local practices, male or female condom with or without spermicide OR cap, diaphragm or sponge with spermicide should be used in addition to one of the highly effective protocol-specified birth control methods (excluding true abstinence). A condom is required in the following countries: UK, Germany and Spain. Female subjects of non-childbearing potential do not need to use birth control.

    Subjects must have been treated for ≥ 3 months with ≥ 1 bDMARD therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration.

    Subjects must have been receiving csDMARD therapy ≥ 3 months prior to M16-063 baseline visit. The following csDMARDs are allowed: oral or parenteral methotrexate (MTX) (7.5 to 25 mg/week), sulfasalazine (≤ 3000 mg/day), hydroxychloroquine (≤ 400 mg/day), chloroquine (≤ 250 mg/day), and leflunomide (≤ 20 mg/day). A combination of up to two background csDMARDs is allowed EXCEPT the combination of MTX and leflunomide.

    Subjects must have discontinued all bDMARDs prior to the first dose of study drug. The washout period for bDMARDs prior to the first dose of study drug is specified below or should be at least five times the mean terminal elimination half-life of a drug:

    - ≥ 4 weeks for etanercept;
    - ≥ 10 weeks for adalimumab, infliximab, certolizumab, golimumab, tocilizumab, and abatacept;
    - ≥ 1 year for rituximab OR ≥ 6 months if B cells have returned to pretreatment level or normal reference range (central lab) if pretreatment levels are not available.

    Subjects must have discontinued all high-potency opiates at least 1 week and oral traditional Chinese medicine for at least 4 weeks prior to the first dose of study.
    • Mujeres o varones adultos, al menos 18 años.
    • Diagnóstico de AR desde ≥ 3 meses basado en el criterio de clasificación 2010 ACR/EULAR para AR
    • Las mujeres no deben estar embarazadas, en periodo de lactancia o considerando quedarse embarazas durante el estudio o aproximadamente 30 días después de la última dosis del estudio.
    • Para todas las mujeres en edad fértil: una prueba de embarazo negativa en suero en la visita de selección y una prueba de embarazo negativa en orina en la visita basal, antes de recibir la primera dosis del fármaco del estudio en el estudio M16-063, así como una prueba de embarazo en orina reiteradamente negativa durante el estudio M16-063 y a la entrada en este estudio.
    • Las mujeres en edad fértil deben practicar al menos 1 de los métodos anticonceptivos especificados en el protocolo, que sea efectivo desde el Día 1 del estudio hasta al menos 30 días. Si se requiere según las prácticas locales, se debe usar un condón masculino o femenino con o sin espermicida o, capuchón cervical, diafragma o esponja con espermicida, además de uno de los métodos anticonceptivos altamente efectivos especificados en el protocolo (excluyendo la abstinencia verdadera). Se requiere el uso de condón en los siguientes países: Reino Unido, Alemania y España. Las mujeres que no se encuentren en edad fértil no necesitan usar métodos anticonceptivos.
    • Los pacientes deben haber sido tratados durante ≥ 3 meses con ≥ 1 terapia con FARME biológicos pero continúan presentando AR activa o han tenido que suspender el tratamiento debido a cuestiones de intolerancia o toxicidad, independientemente de la duración del tratamiento.
    • Los sujetos deben haber recibido terapia con FARME convencionales durante ≥ 3 meses antes de la visita basal del estudio M16-063. Se permiten los siguientes FARME convencionales: metotrexato (MTX) oral o parenteral (7.5 a 25 mg/semana), sulfasalazina (≤ 3000 mg/día), hidroxicloroquina (≤ 400 mg/día), cloroquina (≤ 250 mg/día) y leflunomida (≤ 20 mg/día). Se permite una combinación de hasta dos FARME convencionales de fondo EXCEPTO la combinación de MTX y leflunomida.
    • Los sujetos deben haber suspendido todos los FARME biológicos antes de la primera dosis del fármaco del estudio. El período de lavado para los FARME biológicos, antes de la primera dosis del fármaco del estudio, se especifica a continuación o debe ser al menos cinco veces la semivida media de eliminación terminal de un fármaco:
    o ≥ 4 semanas para etanercept;
    o ≥10 semanas para adalimumab, infliximab, certolizumab, golimumab, tocilizumab, y abatacept.
    o ≥ 1 año para rituximab o ≥ 6 meses si el número de células B han regresado a los niveles pretratamiento o al rango normal de referencia (laboratorio central) si los niveles pretratamiento no están disponibles.
    o Los sujetos deben haber suspendido todos los opiáceos de alta potencia al menos 1 semana y la medicina tradicional china oral durante al menos 4 semanas antes de la primera dosis de estudio.
    E.4Principal exclusion criteria
    Laboratory values not meeting toxicity management criteria from the M16-063 study

    History of any of the following cardiovascular conditions:

    -Moderate to severe congestive heart failure (New York Heart Association Class III or IV).
    -Recent history (within past 6 months) of cerebrovascular accident (CVA), myocardial infarction, and/or coronary stenting.
    -Uncontrolled hypertension as defined by a persistent systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg. For subjects with known hypertension, the subject's BP must be stable for at least 4 weeks on current, stable anti-hypertensive medications.
    -Prior unprovoked deep vein thrombosis (DVT) or pulmonary embolism (PE) (i.e., any spontaneous event not directly attributable to trauma or vascular instrumentation).
    -Any other condition which, in the opinion of the Investigator, would put the subject at risk by participating in the protocol.

    Arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms], or any arthritis with onset prior to age 17 years). Current diagnosis of secondary Sjogren's Syndrome is permitted.

    Must not have been treated with any investigational drug, other than those supplied in M16-063, within 30 days or five half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study, other than M16-063.

    Must not have any active or recurrent viral infection that, based on the Investigator's clinical assessment, makes the subject an unsuitable candidate for the study, including hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, disseminated (even a single episode) herpes simplex, or HIV.

    Active HBV, HCV, and HIV are defined as:
    - HBV: Hepatitis B surface antigen (HBs Ag) positive (+) or, for hepatitis B core antibody (HBc Ab) positive subjects, detection of HBV DNA by polymerase chain reaction (PCR);
    - HCV: HCV RNA detectable in any subject with anti-HCV antibody (HCV Ab);
    - HIV: Confirmed positive anti-HIV antibody (HIV Ab) test.

    Have active TB or meets TB exclusionary parameters (defined as the presence of active TB or latent TB not adequately treated as per protocol requirements).

    Have used known strong cytochrome P450 (CYP)3A or CYP1A2 inhibitors or strong CYP3A or CYP1A2 inducers from Screening through the end of the study.

    Receipt of any live vaccine within 4 weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of oral study drug.

    History of any malignancy except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.

    History of clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
    History of gastrointestinal perforation (other than appendicitis or penetrating injury), diverticulitis or significantly increased risk for gastrointestinal perforation per investigator judgment.

    Any conditions that could interfere with drug absorption including but not limited to short bowel syndrome.

    Recipient of an organ transplant.

    History of clinically significant medical conditions or any other reason that in the opinion of the Investigator would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.

    Active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral anti-infectives within 14 days prior to the first dose of study drug.

    History of an allergic reaction or significant sensitivity to constituents of the study drugs (and its excipients) and/or other products in the same class.
    • Valores de laboratorio que no cumplen con los criterios de manejo de toxicidad del estudio M16-063.
    • Historial de cualquiera de las siguientes condiciones cardiovasculares:
    o Insuficiencia cardíaca congestiva moderada a grave (clase III o IV de la New York Heart Association).
    o Antecedentes recientes (en los últimos 6 meses) de accidente cerebrovascular (ACV), infarto de miocardio y/o colocación de stent coronario.
    o Hipertensión no controlada definida por una presión arterial sistólica (PA) persistente >160 mmHg o presión arterial diastólica >100 mmHg. Para los sujetos con hipertensión conocida, la PA del sujeto debe permanecer estable durante al menos 4 semanas en dosis estables de sus medicamentos antihipertensivos actuales.
    o Previa trombosis venosa profunda (TVP) no provocada o embolia pulmonar (EP) (por ejemplo, cualquier evento espontáneo no atribuible directamente a traumatismo o instrumentación vascular).
    o Cualquier otra condición que, en opinión del investigador, ponga al sujeto en riesgo con su participación en el protocolo.
    • Inicio de la artritis antes de los 17 años o diagnóstico actual de enfermedad articular inflamatoria distinta a la AR (que incluye, entre otras, gota, lupus eritematoso sistémico, artritis psoriásica, espondiloartritis axial que incluye espondilitis anquilosante y espondiloartritis axial no radiológica, artritis reactiva, enfermedad mixta del tejido conectivo, esclerodermia, polimiositis, dermatomiositis, fibromialgia [actualmente con síntomas activos] o cualquier artritis que se presente antes de los 17 años de edad). Se permite el diagnóstico actual del síndrome de Sjogren secundario.
    • No deben haber sido tratados con ningún medicamento en investigación, aparte de los suministrados en el estudio M16-063, dentro de los 30 días o 5 vidas medias del medicamento (lo que sea más largo) antes de la primera dosis del medicamento del estudio o que esté actualmente inscrito en otro ensayo clínico distinto al M16-063.
    • No debe tener ninguna infección viral activa o recurrente que, según la evaluación clínica del Investigador, haga que el sujeto sea un candidato no apto para el estudio, incluyendo el virus de la hepatitis B (VHB) o el virus de la hepatitis C (VHC), herpes zoster recurrente o diseminado (incluso un único episodio), herpes simple diseminado (incluso un único episodio), o VIH.
    El VHB, VHC y VIH activo se define como:
    o VHB: antígeno de superficie de la hepatitis B (HBs Ag) positivo (+) o, para sujetos con el anticuerpo del núcleo (HBc Ab) positivo, detección del ADN del VHB mediante la reacción en cadena de la polimerasa (PCR).
    o VHC: ARN del VHC detectable en cualquier sujeto con anticuerpos anti-VHC (VHC Ab).
    o VIH: prueba confirmatoria positiva de presencia de anticuerpos anti-VIH (VIH Ab).
    • Tener tuberculosis (TB) activa o cumplir con los parámetros de exclusión de TB (definidos como la presencia de TB activa o TB latente no tratada adecuadamente según los requisitos del protocolo).
    • Haber usado inhibidores potentes conocidos del citocromo P45 (CYP)3A o CYP1A2 o inductores potentes de CYP3A o CYP1A2 desde el periodo de selección hasta el final del estudio.
    • Recibir cualquier vacuna viva dentro de las 4 semanas previas a la primera dosis del fármaco del estudio, o la necesidad prevista de vacunación viva durante la participación en el estudio, incluyendo al menos 4 semanas tras la última dosis del fármaco oral del estudio.
    • Historial de cualquier malignidad, excepto el cáncer de piel no-melanoma (NMSC, por sus siglas en inglés) tratado exitosamente o el carcinoma de cuello uterino in situ localizado.
    • Historial de abuso de drogas o alcohol clínicamente significativo (según el criterio del investigador) en los últimos 6 meses.
    • Historial de perforación gastrointestinal (que no sea apendicitis o lesión penetrante), diverticulitis o riesgo significativamente mayor de perforación gastrointestinal según el criterio del investigador.
    • Cualquier condición que pueda interferir con la absorción del fármaco, incluyendo, entre otras, el síndrome del intestino corto.
    • Ser receptor de un trasplante de órgano.
    • Historial de afecciones médicas clínicamente significativas o cualquier otra razón que, en opinión del investigador, pueda interferir con la participación del sujeto en este estudio o lo convierta en un candidato no apto para recibir el fármaco del estudio.
    • Infección(es) activa(s) que requieran tratamiento con antiinfecciosos parenterales dentro de los 30 días, o antiinfecciosos orales dentro de los 14 días anteriores a la primera dosis del fármaco del estudio.
    • Historial de reacción alérgica o sensibilidad significativa a los constituyentes de los medicamentos del estudio (y sus excipientes) y/u otros productos de la misma clase.
    E.5 End points
    E.5.1Primary end point(s)
    Change in disease activity score (DAS)28 (C-reactive protein [CRP]) from baseline of Study M16-063.
    Cambio en el índice de actividad de la enfermedad DAS28 (proteína C-reactiva [PCR]) desde el inicio del estudio M16-063.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12/Baseline, Week 18, Week 24, Week 30, Week 36, Week 48, Week 60/Premature Discontinuation.
    Semana 12 / Inicio, Semana 18, Semana 24, Semana 30, Semana 36, Semana 48, Semana 60 / Descontinuación prematura.
    E.5.2Secondary end point(s)
    Proportion of subjects achieving DAS Low Disease Activity (LDA), defined as DAS28 CRP ≤3.2;
    Proportion of subjects achieving DAS Clinical Remission (CR), defined as DAS28 CRP < 2.6;
    Proportion of subjects achieving American College of Rheumatology (ACR) 20/50/70 response.
    • Proporción de sujetos que alcanzaron una actividad de la enfermedad DAS baja (LDA, por sus siglas en inglés), definida como DAS28 PCR ≤3.2;
    • Proporción de sujetos que alcanzaron la remisión clínica (RC) DAS, definida como DAS28 PCR <2.6;
    • Proporción de sujetos que obtuvieron una respuesta del 20/50/70 del American College of Rheumatology (ACR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12/Baseline, Week 18, Week 24, Week 30, Week 36, Week 48, Week 60/Premature Discontinuation.
    Semana 12 / Inicio, Semana 18, Semana 24, Semana 30, Semana 36, Semana 48, Semana 60 / Descontinuación prematura.
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Treatments continue from M16-063, except those initially assigned placebo (switching to ABBV-599).
    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 trial5
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Belgium
    Canada
    Czech Republic
    Germany
    Hungary
    Poland
    Spain
    United Kingdom
    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
    The end of study is defined as the date of the last subject's last contact, which will be a follow-up phone call 30 days after the last dose.
    El fin del estudio está definido como la fecha del último contacto con el último sujeto, que será una llamada telefónica de seguimiento 30 días después de la última dosis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 120
    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)
    Return to standard of care as needed.
    Regresar al estándar de cuidado si es necesario.
    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 Decision2019-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA