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

14 avril 2011 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

154

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Autres noms:
  • ABT-D2E7
  • Humira
Expérimental: 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.
Biologique: adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Autres noms:
  • ABT-D2E7
  • Humira
Comparateur placebo: Placebo
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Médicament: Placebo
Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Achieving Clinical Response at Week 16
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Abbott

Les enquêteurs

  • Directeur d'études: Martin Okun, MD, PhD, Abbott

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2009

Achèvement primaire (Réel)

1 mars 2010

Achèvement de l'étude (Réel)

1 novembre 2010

Dates d'inscription aux études

Première soumission

30 avril 2009

Première soumission répondant aux critères de contrôle qualité

10 juin 2009

Première publication (Estimation)

11 juin 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

9 mai 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 avril 2011

Dernière vérification

1 avril 2011

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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