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- Ensayo clínico NCT00132769
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
29 de julio de 2015 actualizado por: Merck Sharp & Dohme LLC
A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis
This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
106
Fase
- Fase 2
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 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications
- Other criteria also apply
Exclusion Criteria:
- Other major illnesses
- Past history of certain other disorders
- Certain prohibited medications
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: MK-0873
MK-0873 1.25 mg twice daily for 12 weeks
|
MK-0873 1.25 mg twice daily for 12 weeks
|
Comparador de placebos: Placebo
Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
|
Matching placebo to MK-0873 1.25 mg twice daily for 12 weeks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Swollen Joint Count
Periodo de tiempo: Baseline and the average of Treatment Weeks 8, 10 and 12
|
Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics.
The total number of joints graded 1, 2, or 3 were then counted to yield the SJC.
SJC ranged from 1-66, with increasing score indicating greater number of swollen joints.
SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean.
Change from Baseline = Treatment Period Mean SJC - Baseline SJC.
|
Baseline and the average of Treatment Weeks 8, 10 and 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants With American College of Rheumatology 20% Response [ACR20]
Periodo de tiempo: Baseline and the average of Treatment Weeks 8, 10 and 12
|
Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]).
The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.
|
Baseline and the average of Treatment Weeks 8, 10 and 12
|
Change From Baseline in Tender Joint Count
Periodo de tiempo: Baseline and the average of Treatment Weeks 8, 10 and 12
|
Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws.
The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC.
TJC ranges from 1-68, with increasing score indicating greater number of tender joints.
TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean.
Change from Baseline = Treatment Period Mean TJC - Baseline TJC.
|
Baseline and the average of Treatment Weeks 8, 10 and 12
|
Patient Global Assessment of Disease Activity
Periodo de tiempo: The average of Treatment Weeks 8, 10 and 12
|
At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: "Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing."
The VAS ranges from "Very Well" (0) to "Very Poor" (100).
The mean score at Treatment Weeks 8, 10 and 12 was calculated.
A lower score indicates a better disease activity.
|
The average of Treatment Weeks 8, 10 and 12
|
Investigator Global Assessment of Disease Activity
Periodo de tiempo: Treatment Week 12
|
At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5).
A lower score indicates a more positive assessment of participant disease activity.
|
Treatment Week 12
|
Patient Global Assessment of Response to Therapy
Periodo de tiempo: Treatment Week 12
|
Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4).
A higher score indicates a more positive response to study drug.
|
Treatment Week 12
|
Health Assessment Questionnaire Disability Index
Periodo de tiempo: The average of Treatment Weeks 8, 10 and 12
|
The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.
Responses range from 0=No disability to 3=Completely disabled.
The score for each category subscale is the single response within the category with the highest score (greatest difficulty).
The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.
|
The average of Treatment Weeks 8, 10 and 12
|
Patient's Assessment of Pain
Periodo de tiempo: Treatment Week 12
|
At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from "No pain" (0) to "Extreme pain" (100).
A lower score indicates less pain.
|
Treatment Week 12
|
Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein
Periodo de tiempo: Baseline and the average of Treatment Weeks 8, 10 and 12
|
C-reactive protein levels rise in response to inflammation in the body.
The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect.
On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12.
A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.
|
Baseline and the average of Treatment Weeks 8, 10 and 12
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 enero de 2005
Finalización primaria (Actual)
1 de noviembre de 2005
Finalización del estudio (Actual)
1 de noviembre de 2005
Fechas de registro del estudio
Enviado por primera vez
2 de agosto de 2005
Primero enviado que cumplió con los criterios de control de calidad
19 de agosto de 2005
Publicado por primera vez (Estimar)
22 de agosto de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2015
Última verificación
1 de julio de 2015
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
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Inhibidores de la fosfodiesterasa
- Inhibidores de la fosfodiesterasa 4
- MK 0873
Otros números de identificación del estudio
- 0873-012
- 2005_029 (Otro identificador: Telerex Study Number)
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. .
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