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Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis

14 de octubre de 2015 actualizado por: Novartis Pharmaceuticals

Randomized, Double-blind Placebo-controlled Multi-center Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Psoriatic Arthritis

This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

42

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

  • Alemania
      • Berlin, Alemania, 12203
        • Novartis Investigative Site
      • Hamburg, Alemania, 22081
        • Novartis Investigative Site
      • Hamburg, Alemania, 22415
        • Novartis Investigative Site
      • Herne, Alemania, 44649
        • Novartis Investigative Site
      • Muenchen, Alemania, 80336
        • Novartis Investigative Site
  • Países Bajos
    • DE
      • Amsterdamn, DE, Países Bajos, 1100
        • Novartis Investigative Site
    • KR
      • Meerssen, KR, Países Bajos, 6231
        • Novartis Investigative Site
  • Reino Unido
      • Glasgow, Reino Unido, G12 8TA
        • Novartis Investigative Site
      • Leeds, Reino Unido, LS7 4SA
        • Novartis Investigative Site
      • Newcastle upon Tyne, Reino Unido, NE2 4HH
        • Novartis Investigative Site

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:

  • A diagnosis of psoriatic arthritis

Exclusion Criteria:

  • Patients with arthritis or ankylosing spondyitis
  • Drug-induced psoriasis
  • Male or female patients who plan to conceive during the time course of the study, or for 6 months after the administration of the second dose.
  • Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
  • Previous use of immunosuppressive agents eg cyclosporine, without the necessary wash-out period
  • History of severe allergy to food or drugs
  • Positive TB test. Other protocol-defined inclusion/exclusion criteria may apply

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: AIN457 (2x 10mg/kg)
Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
Biológico: AIN457
The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.
Comparador de placebos: Placebo
Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
Biológico: Placebo
Matching placebo to AIN457

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of ACR Responders Per Treatment at Week 6
Periodo de tiempo: week 6
A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)
week 6
Percentage of PsARC Responders Per Treatment at Week 6
Periodo de tiempo: week 6

Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity

A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)
week 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria
Periodo de tiempo: Day 8 and 15, Weeks 6, 8, 12, 16 and 24
A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)
Day 8 and 15, Weeks 6, 8, 12, 16 and 24
Percentage of Participants Who Achieved PsARC Response
Periodo de tiempo: Day 8 and 15, Weeks 6, 8, 12, 16 and 24
responder" defined as 20% or more improvement in at least 4 of 6 criteria: 1) swollen joint count, 2) tender joint count, 3) morning stiffness duration (low back), 4) current low back pain, 5) current peripheral joint pain, 6) patient global assessment A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)
Day 8 and 15, Weeks 6, 8, 12, 16 and 24
Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment
Periodo de tiempo: Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24
The MASES included assessments of 13 sites. Enthesitis sites included in the MASES index are: 1st costochondral, 7th costochondral, posterior superior iliac spine, anterior superior iliac spine, iliac crest (all above was assessed bilaterally), 5th lumbar spinous process, proximal Achilles (bilateral). The MASES score is defined as the total number of painful MASES entheses. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).
Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24
Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment
Periodo de tiempo: Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24
The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper and lower limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness, and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease).
Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24
SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment
Periodo de tiempo: Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
SPARCC evaluated 18 enthesis sites: medial and lateral epicondyle humerus, supraspinatus insertion, proximal Achilles, greater trochanter, medial and lateral condyl femur, insertion of plantar fascia, quadriceps insertion of patella, inferior pole of patella, and tibial tubercle. SPARCC enthesis index is defined as the total number of painful entheses assessed at the SPARCC sites. Total SI joint scores could range from 0 to 78, with a higher score indicating more signs of disease.
Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment
Periodo de tiempo: Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
The LDI basic measured the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference was multiplied by a tenderness score, using a modification of LDI which was a binary score (1 for tender, 0 for non-tender). If both sides were considered involved, the number was compared to data provided in a table. This modification was referred to as LDI basic and was applied in this study. The LDI required a tool to measure digital circumference and this tool was provided to the centers.
Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment
Periodo de tiempo: Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24
The Disease Activity Score (DAS) is a combined index to measure disease activity in arthritic patients. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) Based on the patients global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 - 100). Using the data from these variables, DAS28 is calculated using the following formula: DAS28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28 score from 0 to 10 indicating the current activity of the rheumatoid arthritis of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24
Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Periodo de tiempo: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration
Periodo de tiempo: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)
Periodo de tiempo: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
Periodo de tiempo: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)
Periodo de tiempo: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
Periodo de tiempo: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

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 marzo de 2009

Finalización primaria (Actual)

1 de diciembre de 2010

Finalización del estudio (Actual)

1 de diciembre de 2010

Fechas de registro del estudio

Enviado por primera vez

16 de diciembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

16 de diciembre de 2008

Publicado por primera vez (Estimar)

17 de diciembre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de noviembre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

14 de octubre de 2015

Última verificación

1 de octubre de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CAIN457A2206

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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