Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

14 aprile 2011 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

154

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Biologico: adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Altri nomi:
  • ABT-D2E7
  • Umira
Sperimentale: 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.
Biologico: adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Altri nomi:
  • ABT-D2E7
  • Umira
Comparatore placebo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving Clinical Response at Week 16
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Abbott

Investigatori

  • Direttore dello studio: Martin Okun, MD, PhD, Abbott

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2009

Completamento primario (Effettivo)

1 marzo 2010

Completamento dello studio (Effettivo)

1 novembre 2010

Date di iscrizione allo studio

Primo inviato

30 aprile 2009

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2009

Primo Inserito (Stima)

11 giugno 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

9 maggio 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 aprile 2011

Ultimo verificato

1 aprile 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Idradenite Suppurativa

  • Herlev and Gentofte Hospital
    Attivo, non reclutante
    HIDRAdenite Suppurativa e Malattie CARDIACHE
    Infarto miocardico | Ischemia miocardica | Malattie cardiache | Arresto cardiaco | Ictus | Insufficienza cardiaca, diastolica | Idradenite Suppurativa | Idradenite | Insufficienza cardiaca, sistolica | Disfunzione ventricolare sinistra | Hidradenitis Suppurativa, familiare
    Danimarca

Prove cliniche su adalimumab

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Jordan

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi