Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
9 de marzo de 2022 actualizado por: Pfizer
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7 RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELY CONTROLLED ON METHOTREXATE
CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells.
Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis.
It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
100
Fase
- Fase 2
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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Ceska Lipa, Chequia, 470 01
- Revmatologicka ambulance
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Praha 2, Chequia, 128 50
- Revmatologicky ustav
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Praha 4, Chequia, 140 00
- Revmatologicka ambulance
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Santiago, RM
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Providencia, Santiago, RM, Chile, 7530206
- Clínica Santa María, Sección Reumatología
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Incheon, Corea, república de, 400-711
- Inha University Hospital, Medicine/Rheumatology
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Pusan, Corea, república de, 602-739
- Pusan National University Hospital, Rheumatology, Internal Medicine
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A Coruña, España, 15006
- Complexo Hospitalario Universitario A Coruña
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Madrid, España, 28007
- Hospital General Universitario Gregorio Maranon
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A Coruña
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Santiago de Compostela, A Coruña, España, 15705
- Hospital Nuestra Señora de La Esperanza
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Arizona
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Mesa, Arizona, Estados Unidos, 85202
- Arizona Arthritis & Rheumatology Associates, P.C.
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Florida
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DeBary, Florida, Estados Unidos, 32713
- Omega Research Consultants LLC
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Lake Mary, Florida, Estados Unidos, 32746
- Florida Arthritis Center
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Tampa, Florida, Estados Unidos, 33614
- Tampa Medical Group, Pa
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Indiana
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Avon, Indiana, Estados Unidos, 46123
- American Health Network
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70115
- George Stanley Walker, MD
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New Orleans, Louisiana, Estados Unidos, 70115
- Best Clinical Trials, LLC (Administrative Only)
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New Orleans, Louisiana, Estados Unidos, 70115
- Majid Abdul Jawad, MD
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Maryland
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Frederick, Maryland, Estados Unidos, 21702
- The Arthritis and Osteoporosis Center of Maryland
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Missouri
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Columbia, Missouri, Estados Unidos, 65212
- University of Missouri-Columbia
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Columbia, Missouri, Estados Unidos, 65203
- University Physicians
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Nevada
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Reno, Nevada, Estados Unidos, 89502
- Arthritis Center of Reno
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- New Horizons Clinical Research
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Washington
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Spokane, Washington, Estados Unidos, 99204-2336
- Arthritis Northwest
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D.f.
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Mexico, D.f., México, 03300
- Investigadores Clinicos Asociados
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Krakow, Polonia, 31-501
- Krakowskie Centrum Medyczne NZOZ
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Poznan, Polonia, 60-356
- Zaklad Reumatologii i Immunologii Klinicznej
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Poznan, Polonia, 61-545
- Oddzial Reumatologiczno-Rehabilitacyjny IIR Ortopedyczno-Rehabilitacyjny
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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 a 99 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Active rheumatoid arthritis
- Incomplete response to methotrexate
Exclusion Criteria:
- Must not be on biologic therapies
- No recent infections
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
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sin ingrediente activo
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Experimental: Activo
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500 mg po BID
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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 American College of Rheumatology 20% (ACR20) Response at Week 12
Periodo de tiempo: Week 12
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ACR20 response: compared to baseline, greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
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Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
Periodo de tiempo: Week 2, 4, 8
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ACR20 response: compared to baseline, >=20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
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Week 2, 4, 8
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Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Periodo de tiempo: Week 2, 4, 8, 12
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ACR50 response: compared to baseline, >=50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
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Week 2, 4, 8, 12
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Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Periodo de tiempo: Week 2, 4, 8, 12
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ACR70 response: compared to baseline, >=70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
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Week 2, 4, 8, 12
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Number of Tender/Painful and Swollen Joints
Periodo de tiempo: Baseline, Week 2, 4, 8, 12
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Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.
The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.
The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
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Baseline, Week 2, 4, 8, 12
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Physician Global Assessment (PGA) of Arthritis
Periodo de tiempo: Baseline, Week 2, 4, 8, 12
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Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor.
This was an evaluation based on the participant's disease signs, functional capacity and physical examination.
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Baseline, Week 2, 4, 8, 12
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Patient's Global Assessment of Arthritis
Periodo de tiempo: Baseline, Week 2, 4, 8, 12
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Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?"
Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly.
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Baseline, Week 2, 4, 8, 12
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Patient's Global Assessment of Arthritic Pain
Periodo de tiempo: Baseline, Week 2, 4, 8, 12
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Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain.
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Baseline, Week 2, 4, 8, 12
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Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Periodo de tiempo: Baseline, Week 2, 4, 8, 12
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Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
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 0-3 where 0= least difficulty and 3= extreme difficulty.
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Baseline, Week 2, 4, 8, 12
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Periodo de tiempo: Baseline, Week 2, 4, 8, 12
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DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter [mg/L]).
Total score range: 0 to 9.4, higher score indicated more disease activity.
DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
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Baseline, Week 2, 4, 8, 12
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C-Reactive Protein (CRP)
Periodo de tiempo: Baseline, Week 2, 4, 8, 12
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
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Baseline, Week 2, 4, 8, 12
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Incidence of Withdrawal Due to Lack of Efficacy
Periodo de tiempo: Week 2, 4, 8, 12, 14
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Number of participants who withrew due to lack of efficacy were reported.
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Week 2, 4, 8, 12, 14
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Time to Withdrawal Due to Lack of Efficacy
Periodo de tiempo: Baseline up to Week 14
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Baseline up to Week 14
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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CE-224,535 Plasma Concentrations
Periodo de tiempo: 0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4
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Nominal times were used for summarizing the pharmacokinetic results (0 hours at randomization [Day 1] and Week 4 [pre-dose]; 1 hour at Week 2 [post-dose]; 2 hours at randomization [post-dose on Day 1]; and 3 hours at Week 2 [post-dose] and Week 4 [post-dose]).
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0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4
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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 (Actual)
7 de abril de 2008
Finalización primaria (Actual)
4 de febrero de 2009
Finalización del estudio (Actual)
4 de febrero de 2009
Fechas de registro del estudio
Enviado por primera vez
25 de febrero de 2008
Primero enviado que cumplió con los criterios de control de calidad
25 de febrero de 2008
Publicado por primera vez (Estimar)
4 de marzo de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
9 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A6341009
- 2008-000327-25 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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. .