- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01668641
Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
26 de junio de 2013 actualizado por: Galapagos NV
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone
- Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks.
- During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
91
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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Moscow, Federación Rusa
- State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
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Ryazan, Federación Rusa
- State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
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Saint-Petersburg, Federación Rusa
- Saint-Petersburg State Healthcare Institution 'City Hospital #26'
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Saint-Petersburg, Federación Rusa
- Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
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Yaroslavl, Federación Rusa
- Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
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Budapest, Hungría
- Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
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Budapest, Hungría
- Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
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Eger, Hungría
- Markhot Ferenc Korhaz, Reumatologiai Osztaly
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Kistarcsa, Hungría
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
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Chisinau, Moldavia, República de
- IMSP Institutel de Cardiologie
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Chernivtsi, Ucrania
- Chernivtsi Regional Clinical Hospital
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Donetsk, Ucrania
- State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
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Kharkiv, Ucrania
- Communal Institution of Healthcare
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Kharkiv, Ucrania
- Institution of Therapy of AMS of Ukraine
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Kharkiv, Ucrania
- State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine'
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Kiev, Ucrania
- State Institution 'Republican Clinical Hospital of MoH of Ukraine'
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Lutsk, Ucrania
- Lutsk City Clinical Hospital
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Vinnytsa, Ucrania
- Vinnytsa Regional Clinical Hospital
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Zaporizhzhia, Ucrania
- Zaporizhzhia Regional Clinical 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 a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL;
- Have received methotrexate for 12 weeks or longer and at a stable dose of 7.5 to 25 mg/week for at least 4 weeks prior to screening and willing to continue on this regimen for the duration of the study;
- If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least 4 weeks prior to screening;
- If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 weeks prior to screening;
- Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year;
- Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study drug.
- Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and
- Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments.
Exclusion Criteria:
- Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate;
- Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents);
- Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening;
- Previous use of the study drug GLPG0634;
- Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening;
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator;
- Positive serology for HIV1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A;
- History of any inflammatory rheumatological disorders other than RA;
- History of tuberculosis (TB) infection
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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Experimental: capsule, 30mg GLPG0634 once a day
3 capsules of 10 mg once a day
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Experimental: capsules, 75mg GLPG0634 once a day
3 capsules of 25mg once a day
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Experimental: capsules, 150mg GLPG0634 once a day
3 capsules of 50mg once a day
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Experimental: capsules, 300mg GLPG0634 once a day
3 capsules of 100mg once a day
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Comparador de placebos: capsules, placebo once a day
3 capsules placebo once a day
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The number of patients with an ACR20 score at Week 4 as a measure of efficacy
Periodo de tiempo: Week 4 (end of treatment visit)
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To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4
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Week 4 (end of treatment visit)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy
Periodo de tiempo: From Day -1 up to end of treatment visit (week 4)
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To evaluate the efficacy of GLPG0634 compared to placebo in terms of ACR response criteria at every visit (ACR20, ACR50, ACR70), time to response, and disease status (DAS28[C-reactive protein, CRP]
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From Day -1 up to end of treatment visit (week 4)
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The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability
Periodo de tiempo: From screening up to 10 days after last dose
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To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs), laboratory test abnormalities, vital signs and electrocardiogram (ECG)
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From screening up to 10 days after last dose
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The plasma levels of GLPG0634 as a measure of PK
Periodo de tiempo: Week 1, week 2 and week 4 visits
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To characterize the pharmacokinetics (PK) of GLPG0634 by measuring the amount of GLPG0634 in the plasma
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Week 1, week 2 and week 4 visits
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The plasma levels of GLPG0634 and MTX as a measure of PK
Periodo de tiempo: Day -1 and Week 2 or 4 visit (8 hour-sampling)
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To explore the potential interaction of GLPG0634 on MTX by assessing steady state PK in an 8-hour sampling at Day -1 and at Week 2 or Week 4 visit in a subset of patients
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Day -1 and Week 2 or 4 visit (8 hour-sampling)
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The levels of immune- and inflammation-related parameters in plasma as a measure of PD
Periodo de tiempo: Day -1, Week 1, week 2 and week 4 visits
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To characterize the pharmacodynamics (PD) of GLPG0634 by measuring the levels of immune- and inflammation-related parameters in plasma
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Day -1, Week 1, week 2 and week 4 visits
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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 mayo de 2012
Finalización primaria (Actual)
1 de septiembre de 2012
Finalización del estudio (Actual)
1 de octubre de 2012
Fechas de registro del estudio
Enviado por primera vez
14 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
16 de agosto de 2012
Publicado por primera vez (Estimar)
20 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
27 de junio de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
26 de junio de 2013
Última verificación
1 de junio de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GLPG0634-CL-202
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. .