Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
14 april 2011 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
154
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Copenhagen NV, Denemarken, 2400
- Site Ref # / Investigator 18683
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Roskilde, Denemarken, 4000
- Site Ref # / Investigator 18684
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Dessau, Duitsland, 06847
- Site Ref # / Investigator 18471
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Kiel, Duitsland, 24105
- Site Ref # / Investigator 18469
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Amsterdam, Nederland, 1105 AZ
- Site Ref # / Investigator 18470
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Rotterdam, Nederland, 3015 CA
- Site Ref # / Investigator 18468
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35205
- Site Ref # / Investigator 19062
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California
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Bakerfield, California, Verenigde Staten, 93309
- Site Ref # / Investigator 18201
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Los Angeles, California, Verenigde Staten, 90045
- Site Ref # / Investigator 18467
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San Diego, California, Verenigde Staten, 92103
- Site Ref # / Investigator 18207
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Florida
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Miami, Florida, Verenigde Staten, 33136
- Site Ref # / Investigator 18204
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30327
- Site Ref # / Investigator 18209
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Illinois
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Skokie, Illinois, Verenigde Staten, 60077
- Site Ref # / Investigator 18202
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Indiana
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Evansville, Indiana, Verenigde Staten, 47714
- Site Ref # / Investigator 18211
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02111
- Site Ref # / Investigator 18203
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Boston, Massachusetts, Verenigde Staten, 02114
- Site Ref # / Investigator 18210
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Missouri
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St Louis, Missouri, Verenigde Staten, 63104
- Site Ref # / Investigator 18461
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68144
- Site Ref # / Investigator 18466
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New York
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New York, New York, Verenigde Staten, 10016
- Site Ref # / Investigator 19141
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New York, New York, Verenigde Staten, 10019
- Site Ref # / Investigator 18208
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27103
- Site Ref # / Investigator 19001
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Pennsylvania
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Hershey, Pennsylvania, Verenigde Staten, 17033
- Site Ref # / Investigator 18981
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Site Ref # / Investigator 18464
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Texas
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Dallas, Texas, Verenigde Staten, 75246-1613
- Site Ref # / Investigator 19061
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San Antonio, Texas, Verenigde Staten, 78258
- Site Ref # / Investigator 18463
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23507
- Site Ref # / Investigator 18206
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Andere namen:
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Experimenteel: 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.
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Subcutaneous injection using prefilled syringe containing adalimumab 40 mg in 0.8 milliliters
Andere namen:
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Placebo-vergelijker: Placebo
Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
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Subcutaneous injection using prefilled syringe containing 0.8 milliliters
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants Achieving Clinical Response at Week 16
Tijdsspanne: Baseline, Week 16
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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).
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Baseline, Week 16
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16
Tijdsspanne: Baseline, Week 16
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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.
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Baseline, Week 16
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Percentage of Participants Achieving Clinical Response at Week 2
Tijdsspanne: Baseline, Week 2
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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).
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Baseline, Week 2
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Percentage of Participants Achieving Clinical Response at Week 4
Tijdsspanne: Baseline, Week 4
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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).
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Baseline, Week 4
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Percentage of Participants Achieving Clinical Response at Week 8
Tijdsspanne: Baseline, Week 8
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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).
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Baseline, Week 8
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Percentage of Participants Achieving Clinical Response at Week 12
Tijdsspanne: Baseline, Week 12
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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).
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Baseline, Week 12
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Change From Baseline in Modified Sartorius Scale at Week 16
Tijdsspanne: Baseline, Week 16
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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.
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Baseline, Week 16
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Change From Baseline in Modified Sartorius Scale at Week 52
Tijdsspanne: Baseline, Week 52
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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.
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Baseline, Week 52
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Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52
Tijdsspanne: Baseline, Week 52
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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.
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Baseline, Week 52
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Martin Okun, MD, PhD, Abbott
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
- Scheinfeld N, Sundaram M, Teixeira H, Gu Y, Okun M. Reduction in pain scores and improvement in depressive symptoms in patients with hidradenitis suppurativa treated with adalimumab in a phase 2, randomized, placebo-controlled trial. Dermatol Online J. 2016 Mar 16;22(3):13030/qt38x5922j.
- Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, Prens EP, Schlessinger J, Zouboulis CC, van der Zee HH, Rosenfeld M, Mulani P, Gu Y, Paulson S, Okun M, Jemec GB. Adalimumab for the treatment of moderate to severe Hidradenitis suppurativa: a parallel randomized trial. Ann Intern Med. 2012 Dec 18;157(12):846-55. doi: 10.7326/0003-4819-157-12-201212180-00004.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2009
Primaire voltooiing (Werkelijk)
1 maart 2010
Studie voltooiing (Werkelijk)
1 november 2010
Studieregistratiedata
Eerst ingediend
30 april 2009
Eerst ingediend dat voldeed aan de QC-criteria
10 juni 2009
Eerst geplaatst (Schatting)
11 juni 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
9 mei 2011
Laatste update ingediend die voldeed aan QC-criteria
14 april 2011
Laatst geverifieerd
1 april 2011
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M10-467
- 2008-004587-38 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .