- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00521924
Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)
14 de marzo de 2017 actualizado por: Merck Sharp & Dohme LLC
Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapy
This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients with low disease activity (Disease Activity Score 28 [DAS28] >2.8 and <3.5) is being conducted to evaluate induction of remission by adding infliximab to pre-existing treatment versus no additional treatment.
All subjects eligible for this study, aged >35 to <=65 years, will have a diagnosis of RA according to American College of Rheumatology (ACR) criteria, and will be offered additional treatment with infliximab.
Prior to the start of treatment, subjects must be on a stable regimen of disease modifying antirheumatic drugs (DMARDs) for at least 3 months.
Subjects will be randomized (1:1) to basic therapy with or without infliximab for a total duration of 38 weeks followed by a follow-up period of up to 6 months.
Subjects randomized to basic therapy + infliximab will receive infliximab 3 mg/kg at Weeks 0, 2, 6, 14, 22, 30, and 38.
The primary objective of the study is to assess the rate of remission according to DAS 28 (<2.6) at the end of treatment (after 38 weeks).
Safety assessments include the incidence of adverse events, serious adverse events, and clinically notable abnormal vital signs and laboratory values.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
8
Fase
- Fase 3
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
19 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients aged >35 and <=65 years with a diagnosis of rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria for at least 1 year and no more than 10 years prior to start of therapy; have active disease (Disease Activity Score [DAS] 28 >2.8 and <3.5), with changes in the DAS 28 score <0.6 within the 6 weeks before inclusion; have stable RA basic therapy according to standard criteria for at least 3 months; have a chest X-ray within 1 month prior to first infusion with no evidence of malignancy, infections, or fibrosis; and have screening laboratory test results that meet prespecified criteria. Patient must have at least one swollen joint. Patient must have evidence of erosive disease by x-ray at baseline.
Exclusion Criteria:
Patients were excluded if they met any of the following criteria:
- Women who are pregnant, nursing, or planning pregnancy within 15 months after screening (i.e., approximately 6 months following last infusion);
- Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer;
- History of any other therapeutic agent targeted at reducing tumor necrosis factor (TNF);
- History of previous administration of infliximab;
- History of receiving human/murine recombinant products or has a known allergy to murine products;
- Serious infection (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
- Active tuberculosis (TB) or evidence of latent TB (positive purified protein derivative [PPD] skin test, a history of old or latent TB or chest X-ray without adequate therapy for TB initiated prior to first infusion of study drug), or evidence of an old or latent TB infection without documented adequate therapy. Patients with a current close contact with an individual with active TB and patients who have completed treatment for active TB within the previous 2 years are explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies.
- Hepatitis B surface antigen or Hepatitis C (HCV) antibody positive; documented Human Immunodeficiency Virus (HIV) infection;
- Have an opportunistic infection, including but not limited to evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterium infection, etc, within the previous 6 months;
- Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, psychiatric, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis);
- Concomitant congestive heart failure >= New York Heart Association (NYHA) II;
- Have a transplanted organ (with the exception of a corneal transplant >3 months prior to screening);
- Fibromyalgia;
- Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence);
- History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or peri-aortic areas), or splenomegaly; or
- Known recent substance abuse (drug or alcohol).
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Infliximab + basic treatment
3 mg/kg infliximab plus basic treatment
|
infliximab 3 mg/kg and basic treatment
Otros nombres:
|
Comparador activo: Basic treatment (DMARDs)
Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
|
Methotrexate (15 - 25 mg/week); chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Patients in Remission According to Disease Activity Score (DAS) 28 (< 2.6)
Periodo de tiempo: after 38 weeks
|
The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health.
Patients can be scored on a range of 0 to 10, with lower scores indicating less disease activity.
|
after 38 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
DAS 28 at Baseline vs at Week 38; Quality of Life; American College of Rheumatology (ACR) Response Disease Progression (X-ray); Effect of Inflammatory Markers on Response and Disease Progression; Assess Simplified Disease Activity Index (SDAI).
Periodo de tiempo: Weeks 14, 38, and 62
|
These were not prespecified key secondary outcomes; therefore, results will not be disclosed.
|
Weeks 14, 38, and 62
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 junio de 2007
Finalización primaria (Actual)
1 de abril de 2008
Finalización del estudio (Actual)
1 de abril de 2008
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2007
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2007
Publicado por primera vez (Estimar)
28 de agosto de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
14 de marzo 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
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes del sistema nervioso periférico
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes Gastrointestinales
- Agentes dermatológicos
- Agentes antifúngicos
- Agentes de control reproductivo
- Agentes antiprotozoarios
- Agentes antiparasitarios
- Antipalúdicos
- Amebicidas
- Agentes abortivos, no esteroideos
- Agentes abortivos
- Antagonistas del ácido fólico
- Inhibidores de calcineurina
- Cloroquina
- Metotrexato
- Infliximab
- Ciclosporina
- Ciclosporinas
- Sulfasalazina
- Agentes antirreumáticos
Otros números de identificación del estudio
- P04644
- 2005-004530-40
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
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 infliximab
-
Onze Lieve Vrouwe GasthuisSanteonDesconocido
-
Diakonhjemmet HospitalSouth-Eastern Norway Regional Health AuthorityTerminadoArtritis Reumatoide | Enfermedad de Crohn | Colitis ulcerosa | Artritis psoriásica | Espondiloartritis | Psoriasis crónicaNoruega
-
Merck Sharp & Dohme LLCIntegrated Therapeutics GroupTerminadoArtritis Reumatoide
-
Centre hospitalier de l'Université de Montréal...Ottawa Hospital Research Institute; Maisonneuve-Rosemont Hospital; Niagara Health... y otros colaboradoresReclutamiento
-
PfizerTerminadoPsoriasis vulgar | Psoriasis pustulosa | Psoriasis Artropática | Psoriasis eritrodérmicaJapón
-
Janssen Research & Development, LLCJanssen Biologics BVTerminadoColitis ulcerosaEstados Unidos, Francia, Reino Unido, Bélgica, Suiza, Israel, Canadá, Australia, Países Bajos, Nueva Zelanda, Austria, Alemania, Dinamarca, Chequia, Argentina
-
BiocadTerminadoEspondiloartritis anquilosanteFederación Rusa, Bielorrusia
-
NYU Langone HealthRetiradoEnfermedad inflamatoria intestinal
-
Merck Sharp & Dohme LLCTerminadoEnfermedad de Crohn
-
European Organisation for Research and Treatment...TerminadoSíndromes mielodisplásicosFrancia, Bélgica, Países Bajos, República Checa, Italia, Alemania