- ICH GCP
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- Ensayo clínico NCT02378506
Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
10 de mayo de 2017 actualizado por: Pfizer
A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis
Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process.
Descriptive results will be provided however a formal hypothesis will not be tested in this trial.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
188
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 14059
- Schlosspark-Klinik, Innere Medizin II, Rheumatologie
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Hannover, Alemania, 30625
- Medizinische Hochschule Hannover
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Vogelsang-Gommern, Alemania, 39245
- Immunologisches Zentrum Vogelsang-Gommern GmbH
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Hessen
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Frankfurt/Main, Hessen, Alemania, 60528
- Centrum für innovative Diagnostik und Therapie
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Nordrhein-westfalen
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Ratingen, Nordrhein-westfalen, Alemania, 40882
- Rheumaforschung - Studienambulanz Dr. Wassenberg
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Plovdiv, Bulgaria, 4000
- MHAT Plovdiv
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Sofia, Bulgaria, 1431
- DCC "Aleksandrovska" EOOD
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Sofia, Bulgaria, 1612
- UMHAT "Sv. Ivan Rilski" EAD, Sofia
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Stara Zagora, Bulgaria, 6000
- Medical Center - "New rehabilitation center" EOOD
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Rijeka, Croacia, 51000
- Chc Rijeka
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Zagreb, Croacia, 10000
- Medicinski Centar Kuna Peric
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Bratislava, Eslovaquia, 841 04
- Reumatologicka ambulancia
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Dunajska Streda, Eslovaquia, 929 01
- AAGS, s.r.o.
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Poprad, Eslovaquia, 058 01
- Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.
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Rimavska Sobota, Eslovaquia, 979 01
- REUMEX s.r.o.
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Trnava, Eslovaquia, 917 01
- REUMA-GLOBAL s.r.o.
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Zilina, Eslovaquia, 010 01
- Reumatologicka ambulancia
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Thessaloniki, Grecia, 56429
- Rheumatology Unit
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Achaia
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Rion Patras, Achaia, Grecia, 26500
- Rheumatology department
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Crete
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Heraklion, Crete, Grecia, 71110
- University Hospital Of Heraklion
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Budapest, Hungría, 1036
- Qualiclinic Kft.
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Kistarcsa, Hungría, 2143
- Pest Megyei Flor Ferenc Korhaz
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Nyiregyhaza, Hungría, 4400
- Szabolcs-Szatmar-Bereg megyei
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Krakow, Polonia, 31-501
- Krakowskie Centrum Medyczne sp. Z.O.O
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Nadarzyn, Polonia, 05-830
- NZOZ Lecznica MAK-MED s.c.
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Poznan, Polonia, 61-397
- Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj
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Warszawa, Polonia, 02-691
- Reumatika-Centrum Reumatologii
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Beograd
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Belgrade, Beograd, Serbia, 11000
- Institute of Rheumatology
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Cape Town
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Panorama, Cape Town, Sudáfrica, 7500
- Panorama Medical Centre
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Johannesburg
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Parktown, Johannesburg, Sudáfrica, 2193
- Wits Clinical Research CMJAH Clinical Trial Site
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Kwazulu-natal
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Durban/Berea, Kwazulu-natal, Sudáfrica, 4001
- St. Augustines Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
- Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.
Exclusion Criteria:
- Prior treatment with etanercept.
- Presence of active infection or active or untreated tuberculosis.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: ETN 50mg QW
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50mg subcutaneous, once weekly, 24 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
Periodo de tiempo: Week 12
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Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated.
Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
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Week 12
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Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24
Periodo de tiempo: Week 24
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Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated.
Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
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Week 24
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Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment
Periodo de tiempo: Baseline up to Week 24
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Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated.
Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
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Baseline up to Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment
Periodo de tiempo: Baseline (Day 1) up to Week 24
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Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.
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Baseline (Day 1) up to Week 24
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline (Day 1) up to Week 28 (Follow-up)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
AEs included both serious and non-serious adverse events.
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Baseline (Day 1) up to Week 28 (Follow-up)
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Number of Participants With Investigator-Identified Serious Infections
Periodo de tiempo: Baseline (Day 1) up to Week 28 (Follow-up)
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Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.
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Baseline (Day 1) up to Week 28 (Follow-up)
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Number of Participants With Injection Site Reactions
Periodo de tiempo: Baseline (Day 1) up to Week 28 (Follow-up)
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Injection site reactions included injection site erythema, swelling, pain and warmth.
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Baseline (Day 1) up to Week 28 (Follow-up)
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Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities
Periodo de tiempo: Baseline (Day 1) up to Week 28 (Follow-up)
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Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less
than[<]1.0
10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0
10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper
range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR
micromole per liter[mcmol/L]);creatinine(>3.0*UR,
<=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR,
<=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L).
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Baseline (Day 1) up to Week 28 (Follow-up)
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Periodo de tiempo: Week 4, 12, 24
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ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein.
PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis.
PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis.
Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain.
HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.
Percentage of participants with ACR20 response were reported.
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Week 4, 12, 24
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Periodo de tiempo: Week 4, 12, 24
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ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein.
PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis.
PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis.
Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain.
HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.
Percentage of participants with ACR50 response were reported.
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Week 4, 12, 24
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Periodo de tiempo: Week 4, 12, 24
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ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein.
PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis.
PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis.
Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain.
HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.
Percentage of participants with ACR70 response were reported.
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Week 4, 12, 24
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Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
Periodo de tiempo: Baseline, Week 4, 12, 24
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DAS28: measure of disease activity in participants with rheumatoid arthritis.
DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition).
Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity.
DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.
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Baseline, Week 4, 12, 24
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Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
Periodo de tiempo: Baseline, Week 4, 12, 24
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DAS28 is a measure of disease activity in participants with rheumatoid arthritis.
DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition).
Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity.
DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.
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Baseline, Week 4, 12, 24
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
Periodo de tiempo: Baseline, Week 4, 12, 24
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HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities.
Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
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Baseline, Week 4, 12, 24
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2015
Finalización primaria (Actual)
1 de mayo de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
13 de febrero de 2015
Primero enviado que cumplió con los criterios de control de calidad
26 de febrero de 2015
Publicado por primera vez (Estimar)
4 de marzo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
10 de mayo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Artritis
- Artritis Reumatoide
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Gastrointestinales
- Etanercept
Otros números de identificación del estudio
- B1801359
- 2013-004569-16 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre etanercept
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EMSRetirado
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Shanghai Celgen Bio-Pharmaceutical Co.,LtdDesconocidoSoriasis | Soriasis en placasPorcelana
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AmgenTerminadoArtritis reumatoide; Artritis, PsoriásicaEstados Unidos, Puerto Rico
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Sunshine Guojian Pharmaceutical (Shanghai) Co.,...TerminadoEspondiloartritis anquilosantePorcelana
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AmgenTerminado
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Samsung Bioepis Co., Ltd.TerminadoArtritis ReumatoidePolonia, Reino Unido
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Sun Pharmaceutical Industries LimitedRetirado
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Sun Yat-sen UniversityTerminado
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AmgenTerminado
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PfizerTerminadoPsoriasis moderada a severaCorea, república de