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

14. april 2011 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

154

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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 navn:
  • ABT-D2E7
  • Humira
Eksperimentell: 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 navn:
  • ABT-D2E7
  • Humira
Placebo komparator: Placebo
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
Legemiddel: Placebo
Subcutaneous injection using prefilled syringe containing 0.8 milliliters

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Abbott

Etterforskere

  • Studieleder: Martin Okun, MD, PhD, Abbott

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2009

Primær fullføring (Faktiske)

1. mars 2010

Studiet fullført (Faktiske)

1. november 2010

Datoer for studieregistrering

Først innsendt

30. april 2009

Først innsendt som oppfylte QC-kriteriene

10. juni 2009

Først lagt ut (Anslag)

11. juni 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. mai 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. april 2011

Sist bekreftet

1. april 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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