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

14. april 2011 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

154

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Andre navne:
  • ABT-D2E7
  • Humira
Eksperimentel: 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.
Biologisk: adalimumab
Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Andre navne:
  • ABT-D2E7
  • Humira
Placebo komparator: Placebo
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Medicin: Placebo
Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving Clinical Response at Week 16
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott

Efterforskere

  • Studieleder: Martin Okun, MD, PhD, Abbott

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. marts 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

30. april 2009

Først indsendt, der opfyldte QC-kriterier

10. juni 2009

Først opslået (Skøn)

11. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. maj 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. april 2011

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hidradenitis Suppurativa

Kliniske forsøg med adalimumab

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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