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Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

14 de abril de 2011 actualizado por: Abbott

A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16 through 52). Participants are randomized in a 1:1:1 ratio based on Hurley Stage as stratification factor to receive adalimumab 40 mg every week (qwk), adalimumab 40 mg every other week (eow), or matching placebo during Period 1. During Period 2, participants receive open-label adalimumab 40 mg eow with the option to escalate to 40 mg weekly dosing at Week 28 or Week 31 if the participant has a Physician's Global Assessment of moderate disease or worse (score of greater than or equal to 3). The primary objective of the study is to determine the clinical efficacy and safety of participants with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment. The secondary objective is to evaluate the maintenance of efficacy and continued safety of adalimumab for an additional 36 weeks of treatment. (Note: Hurley Stage is a classification system for skin involvement that is largely based on the presence and extent of abscess formation accompanied by scarring and sinus tracts. Hurley Stages are I [abscess formation without scarring and sinus tracts], II [widely separated recurrent abscesses with scarring and sinus tracts], and III [multiple interconnected abscesses and sinus tracts across entire area]. Randomization in this study was performed using stratification by Hurley Stage [III versus (I or II).) At the present time, Period 1 double-blind data only is provided; additional information will be provided when analysis of open-label Period 2 is completed.

Tipo de estudio

Intervencionista

Inscripción (Actual)

154

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
      • Dessau, Alemania, 06847
        • Site Ref # / Investigator 18471
      • Kiel, Alemania, 24105
        • Site Ref # / Investigator 18469
  • Dinamarca
      • Copenhagen NV, Dinamarca, 2400
        • Site Ref # / Investigator 18683
      • Roskilde, Dinamarca, 4000
        • Site Ref # / Investigator 18684
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35205
        • Site Ref # / Investigator 19062
    • California
      • Bakerfield, California, Estados Unidos, 93309
        • Site Ref # / Investigator 18201
      • Los Angeles, California, Estados Unidos, 90045
        • Site Ref # / Investigator 18467
      • San Diego, California, Estados Unidos, 92103
        • Site Ref # / Investigator 18207
    • Florida
      • Miami, Florida, Estados Unidos, 33136
        • Site Ref # / Investigator 18204
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30327
        • Site Ref # / Investigator 18209
    • Illinois
      • Skokie, Illinois, Estados Unidos, 60077
        • Site Ref # / Investigator 18202
    • Indiana
      • Evansville, Indiana, Estados Unidos, 47714
        • Site Ref # / Investigator 18211
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Site Ref # / Investigator 18203
      • Boston, Massachusetts, Estados Unidos, 02114
        • Site Ref # / Investigator 18210
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63104
        • Site Ref # / Investigator 18461
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68144
        • Site Ref # / Investigator 18466
    • New York
      • New York, New York, Estados Unidos, 10016
        • Site Ref # / Investigator 19141
      • New York, New York, Estados Unidos, 10019
        • Site Ref # / Investigator 18208
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • Site Ref # / Investigator 19001
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Site Ref # / Investigator 18981
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Site Ref # / Investigator 18464
    • Texas
      • Dallas, Texas, Estados Unidos, 75246-1613
        • Site Ref # / Investigator 19061
      • San Antonio, Texas, Estados Unidos, 78258
        • Site Ref # / Investigator 18463
    • Virginia
      • Norfolk, Virginia, Estados Unidos, 23507
        • Site Ref # / Investigator 18206
  • Países Bajos
      • Amsterdam, Países Bajos, 1105 AZ
        • Site Ref # / Investigator 18470
      • Rotterdam, Países Bajos, 3015 CA
        • Site Ref # / Investigator 18468

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adults with stable, moderate to severe hidradenitis suppurativa
  • Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy.
  • Ability to administer subcutaneous injections
  • General good health otherwise

Exclusion Criteria:

  • Prior anti-TNF therapy
  • Unstable antibiotic therapy for HS
  • Required medication washouts for other HS treatments
  • Prior exposure to Tysabri® (natalizumab);
  • Recent infection requiring treatment
  • Significant medical events or conditions that may put patients at risk for participation
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
  • History of cancer, except successfully treated skin cancer
  • Recent history of drug or 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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Adalimumab 40 mg qwk
Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
Biológico: adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Otros nombres:
  • ABT-D2E7
  • Humira
Experimental: Adalimumab 40 mg eow
Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
Biológico: adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Otros nombres:
  • ABT-D2E7
  • Humira
Comparador de placebos: Placebo
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Droga: Placebo
Subcutaneous injection using prefilled syringe containing 0.8 milliliters

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Achieving Clinical Response at Week 16
Periodo de tiempo: Baseline, Week 16
Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Baseline, Week 16

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
Periodo de tiempo: Baseline, Week 16
Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.
Baseline, Week 16
Percentage of Participants Achieving Clinical Response at Week 2
Periodo de tiempo: Baseline, Week 2
Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Baseline, Week 2
Percentage of Participants Achieving Clinical Response at Week 4
Periodo de tiempo: Baseline, Week 4
Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Baseline, Week 4
Percentage of Participants Achieving Clinical Response at Week 8
Periodo de tiempo: Baseline, Week 8
Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Baseline, Week 8
Percentage of Participants Achieving Clinical Response at Week 12
Periodo de tiempo: Baseline, Week 12
Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
Baseline, Week 12
Change From Baseline in Modified Sartorius Scale at Week 16
Periodo de tiempo: Baseline, Week 16
The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
Baseline, Week 16
Change From Baseline in Modified Sartorius Scale at Week 52
Periodo de tiempo: Baseline, Week 52
The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.
Baseline, Week 52
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52
Periodo de tiempo: Baseline, Week 52
Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.
Baseline, Week 52

Colaboradores e Investigadores

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

Patrocinador

Abbott

Investigadores

  • Director de estudio: Martin Okun, MD, PhD, Abbott

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.

Publicaciones Generales

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 abril de 2009

Finalización primaria (Actual)

1 de marzo de 2010

Finalización del estudio (Actual)

1 de noviembre de 2010

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2009

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2009

Publicado por primera vez (Estimar)

11 de junio de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

9 de mayo de 2011

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

14 de abril de 2011

Última verificación

1 de abril de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • M10-467
  • 2008-004587-38 (Número EudraCT)

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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