- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02247375
Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA)
23 de septiembre de 2014 actualizado por: Boehringer Ingelheim
A Double-blind, Randomized, Three Parallel Group Placebo-controlled Study to Investigate Pharmacokinetics, Effect on Expression of CD11b/CD18 (Mac-1), as Well as Safety and Efficacy of Two Oral Doses of BIIL 284 BS (Dosage: 25 mg Daily, 150 mg Daily) in Patients With Rheumatoid Arthritis Over Two Weeks
Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
26
Fase
- Fase 1
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:
- Male and female from 18 to 65 years of age
Patients suffering from active rheumatoid arthritis as defined by the ARA criteria revised 1987
--- At least 4 of the following 7 criteria must have been present:
- morning stiffness in and around the joints lasting at least 1 hour before maximal improvement for at least 6 weeks
- arthritis (soft tissue thickening or fluid - not bony overgrowth alone) of at least 3 joint areas for at least 6 weeks
- arthritis of hand joints (at least one area swollen in a wrist, metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint) for at least 6 weeks
- symmetric arthritis (observed by a physician) with simultaneous involvement of the joints on both sides of the body for at least 6 weeks
- rheumatoid nodules (observed by a physician) over bony prominences or extensor surfaces or in juxta-articular regions
- serum rheumatoid factor positive
- x-ray changes typical of rheumatoid arthritis (erosions or unequivocal bony decalcification localised in or most marked adjacent to the involved joints)
- Patient belonging to the RA functional class I, II or III
- Patient's written informed consent
Exclusion Criteria:
- Pregnancy (to be excluded by pregnancy test) or breast feeding
- Women of childbearing potential not using adequate contraception
- Treatment with methotrexate in the previous month or intended use during the trial period
- Treatment with slow acting antirheumatic drugs (SAARDs)/disease-modifying antirheumatic drugs (DMARDs) other than parenteral gold, D-penicillamine, sulfasalazine, chloroquine / hydroxychloroquine corticosteroid during the last 2 months prior to study entry
- Treatment with more than one SAARD/DMARD and/or corticosteroid during the last 2 months prior to study entry
- Change in treatment with SAARDs/DMARDs during the last 2 months prior to study entry or intended change during the trial duration
- Change in treatment with corticosteroids during the last month prior to study entry or intended change during the trial duration
- Systemic treatment with corticosteroids at a dose higher than 10 mg/day or 0.2 mg/kg/day (prednisone equivalent), respectively (whichever is lower) during the last month prior to study entry or their intended use during the trial treatment period
- Change in treatment with non-steroidal anti-inflammatory drugs (NSAIDs) during the last month prior to study entry or intended change during the trial duration
- Treatment with EnbrelTM (etanercept) or experimental therapies during the last 3 months prior to study entry
- Synovectomy and/or surgical treatment for RA in the previous month or during the trial
- Clinical evidence of known severe cardiovascular, hepatic, renal, respiratory, metabolic, haematological, immunological, gastro-intestinal, hormonal or mental disorders
- Any other rheumatological or non-rheumatological disease that could interfere with the evaluation of efficacy and safety
- Patients with active malignant disease
- Patients with chronic or acute infections during the previous month
- Patients with abnormal, clinically relevant laboratory values not related to RA
- Participation in another clinical trial during this study or during the previous month
- Previous participation in this trial (i.e. having been allocated a randomized treatment number)
- Patient unable to comply with the protocol
- Patient with known drug abuse
- Patient with known alcohol abuse
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 |
---|---|
Comparador de placebos: Placebo
|
|
Experimental: Dosis baja de BIIL 284 BS
|
|
Experimental: Alta dosis de BIIL 284 BS
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Changes from baseline in Mac-1 expression
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
Plasma concentrations of BIIL 284 BS, BIIL 260 BS, BIIL 315 ZW and BIIL 304 ZW
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
Maximum concentration of the analyte in plasma (Cmax)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
Trough concentration of the analyte in plasma shortly before drug administration in a steady state dosing interval (Cpre,ss)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
Time to reach the maximum concentration of the analyte in plasma (tmax)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
Area under the concentration-time curve of the analyte in plasma (AUC)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
Number of patients with adverse events
Periodo de tiempo: Up to 4 weeks
|
Up to 4 weeks
|
Global assessment of tolerability by the patient on a 4-point scale
Periodo de tiempo: Up to 14 days after start of treatment
|
Up to 14 days after start of treatment
|
Global assessment of tolerability by investigator on a 4-point scale
Periodo de tiempo: Up to 14 days after start of treatment
|
Up to 14 days after start of treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes from baseline in tender joint count (TJC)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Bilateral assessment of twenty-eight joints by e.g., pressure, joint manipulation etc.
|
Pre-dose, up to day 14 after start of treatment
|
Changes from baseline in swollen joint count (SJC)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Twenty-eight joints were bilaterally assessed whether they are swollen or not
|
Pre-dose, up to day 14 after start of treatment
|
Changes from baseline in patient's current pain level assessment by visual analogue scale (VAS)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
|
Changes from baseline in patient's global assessment of disease activity by VAS
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
|
Global assessment of disease activity by investigator on a 5-point scale
Periodo de tiempo: Up to 14 days after start of treatment
|
Up to 14 days after start of treatment
|
|
Changes from baseline for patient's assessment of physical function
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Functional disability was measured using the disability section of the Health Assessment Questionnaire (HAQ)
|
Pre-dose, up to day 14 after start of treatment
|
Changes from baseline in erythrocyte sedimentation rate (ESR)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
|
Changes from baseline in C-reactive protein (CRP)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
|
Changes from baseline in american college of rheumatology (ACR) 20 score
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
|
Changes from baseline in disease activity score (DAS)
Periodo de tiempo: Pre-dose, up to day 14 after start of treatment
|
Pre-dose, up to day 14 after start of treatment
|
|
Global efficacy assessment by the patient on a 4-point scale
Periodo de tiempo: Up to 14 days after start of treatment
|
Up to 14 days after start of treatment
|
|
Number of withdrawals due to adverse events
Periodo de tiempo: Up to 4 weeks
|
Up to 4 weeks
|
|
Number of patients with clinically significant findings in laboratory adverse events
Periodo de tiempo: Up to 4 weeks
|
Up to 4 weeks
|
|
Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)
Periodo de tiempo: Up to 4 weeks
|
Up to 4 weeks
|
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.
Enlaces Útiles
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 2000
Finalización primaria (Actual)
1 de mayo de 2000
Fechas de registro del estudio
Enviado por primera vez
19 de septiembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
23 de septiembre de 2014
Publicado por primera vez (Estimar)
25 de septiembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
25 de septiembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
23 de septiembre de 2014
Última verificación
1 de septiembre de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 543.14
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