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Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy

8. dubna 2011 aktualizováno: Abbott
The objective of this study was to evaluate the safety and efficacy profile of Humira (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This open-label study was conducted in a patient population of moderate to severe chronic plaque psoriasis patients, which is an approved patient population for adalimumab.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This 16-week multicenter, open-label study was designed to evaluate the efficacy and safety of a loading dose of 80 mg adalimumab, followed by 40 mg adalimumab every other week in the treatment of psoriasis in patients with a sub-optimal response to etanercept, methotrexate (MTX), or Narrow band Ultraviolet - B (NB-UVB).

Approximately 150 participants were planned for 3 sub-studies: 80 participants with sub-optimal response to etanercept, 40 participants with sub-optimal response to MTX, and 30 participants with sub-optimal response to NB-UVB. Actual enrollment was 82 participants with sub-optimal response to etanercept, 41 participants with sub-optimal response to MTX, and 29 participants with sub-optimal response to NB-UVB.

Screening was performed at least 96 hours and no more than 31 days before the Baseline visit (Week 0). A participant who was eligible for the study based on sub-optimal response to one treatment (MTX, NB-UVB, or etanercept) was required to discontinue that treatment within a specified time before first dose of adalimumab (see descriptions of sub-study groups). In addition, if the participant was also receiving another qualifying treatment, he/she was required to have discontinued the other treatment at least 30 days before the Baseline visit (Week 0).

Adalimumab was administered by subcutaneous (SC) injection. At the Baseline Visit (Week 0), all participants received an initial dose of 80 mg adalimumab SC. Every other week (odd-numbered weeks) from Week 1 to Week 15, participants received 40 mg adalimumab SC.

This was a single group assignment study, that is, all participants received the same treatment; however, data were summarized for 3 groups (sub-studies) that were defined by psoriasis treatments participants received before entering this study: methotrexate, etanercept, or narrow-band, ultraviolet-B.

Efficacy was evaluated using the Physician's Global Assessment (PGA) of disease severity, and patient-reported outcomes: Patient's Global Assessment (PTGA) of disease severity, the Psoriasis-related Pruritus Assessment, the Dermatology Life Quality Index (DLQI), a visual analog scale (VAS) for plaque psoriasis and psoriatic arthritis pain, the Medical Outcomes Study (MOS) Sleep Scale, and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP).

Serious and nonserious adverse events were summarized by sub-study of participants (suboptimal response to MTX, suboptimal response to NB-UVB, and suboptimal response to etanercept).

Typ studie

Intervenční

Zápis (Aktuální)

152

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2S 3B3
        • Kirk Barber Research
      • Edmonton, Alberta, Kanada, T5K 1X3
        • Stratica Medical
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3H 1Z4
        • Eastern Canada Cutaneous Research Associates
    • Ontario
      • Hamilton, Ontario, Kanada, L8N 1V6
        • Dermatrials Research
      • Waterloo, Ontario, Kanada, N2J 1C4
        • K.Papp Clinical Research Inc
    • Quebec
      • Montreal, Quebec, Kanada
        • Siena Medical Research
      • Quebec City, Quebec, Kanada, G1V 4X7
        • Centre de Rescherche Dermatologique Du Quebec Metropolitain
  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35205
        • Total Skin and Beauty Dermatology Centers
    • Arkansas
      • Little Rock, Arkansas, Spojené státy, 72205
        • Dermatology Research of Arkansas
    • California
      • San Diego, California, Spojené státy, 92123
        • Therapeutics Clinical Research
    • Florida
      • Miami, Florida, Spojené státy, 33136
        • Florida Academic Dermatology Centers
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30327
        • Peachtree Dermatology Associates
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46256
        • Dawes Fretzin Clinical Research Group
    • Massachusetts
      • Andover, Massachusetts, Spojené státy, 01810
        • ORA Clinical Research and Development
    • New York
      • Bronx, New York, Spojené státy, 10467
        • Montifiore Medical Center
      • New York, New York, Spojené státy, 10016
        • New York University School of Medicine
      • New York, New York, Spojené státy, 10029
        • Mount Sinai School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19103
        • Paddington Testing Co.
    • Rhode Island
      • Johnston, Rhode Island, Spojené státy, 02919
        • Clinical Partners
    • South Carolina
      • Greer, South Carolina, Spojené státy, 29651
        • Radiant Research
    • Texas
      • Dallas, Texas, Spojené státy, 75246
        • Baylor Research Institute
      • Dallas, Texas, Spojené státy, 75230
        • Dermatology Treatment & Research Center, PA Research
      • Houston, Texas, Spojené státy, 77058
        • Center for Clinical Studies
    • Virginia
      • Norfolk, Virginia, Spojené státy, 23507
        • Virginia Clinical Research, Inc.
    • Washington
      • Seattle, Washington, Spojené státy, 98101
        • Dermatology Associates

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Diagnosis of chronic plaque psoriasis with disease duration of at least 6 months
  • Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB phototherapy

Exclusion Criteria:

  • Prior treatment with adalimumab
  • Multiple concomitant therapy restrictions and/or washouts (topicals, ultraviolet, other systemic psoriasis therapies)
  • Prior treatment with natalizumab
  • Concurrent active skin diseases/infections
  • Poorly controlled medical conditions
  • History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
  • History of certain cancers

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Otevřený
Biologický: adalimumab
Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.
Ostatní jména:
  • ABT-D2E7
  • Humira

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
Časové okno: Week 16
The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe [extreme red coloration, dusky to deep red coloration]).
Week 16

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants Achieving a PGA of Clear (0) at Week 16
Časové okno: Week 16
Week 16
Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening
Časové okno: From Screening to Week 16
From Screening to Week 16
Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8
Časové okno: Weeks 2, 4, and 8
The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.
Weeks 2, 4, and 8
Dermatology Life Quality Index (DLQI) Total Score
Časové okno: From Screening to Week 4 and Week 16
The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0.
From Screening to Week 4 and Week 16
Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16
Časové okno: Week 4 and Week 16
DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.
Week 4 and Week 16
Psoriasis-related Pruritus Assessment
Časové okno: From Screening to Week 16
The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus.
From Screening to Week 16
Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis
Časové okno: From Screening to Week 16
The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement.
From Screening to Week 16
Percent Work Time Missed Due to Psoriasis
Časové okno: From Screening to Week 16
Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%.
From Screening to Week 16
Percent Overall Work Impairment Due to Psoriasis
Časové okno: From Screening to Week 16
Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement.
From Screening to Week 16
Percent Impairment While Working Due to Psoriasis
Časové okno: From Screening to Week 16
Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement.
From Screening to Week 16
Percent Activity Impairment Due to Psoriasis
Časové okno: From Screening to Week 16
Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%.
From Screening to Week 16
Sleep Problems Index II
Časové okno: From Screening to Week 16
Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from "none of the time" to "all of the time" for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement.
From Screening to Week 16

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Abbott

Vyšetřovatelé

  • Ředitel studie: Martin M Okun, M.D., Ph.D., Abbott

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 2008

Primární dokončení (Aktuální)

1. dubna 2009

Dokončení studie (Aktuální)

1. dubna 2009

Termíny zápisu do studia

První předloženo

1. prosince 2007

První předloženo, které splnilo kritéria kontroly kvality

1. prosince 2007

První zveřejněno (Odhad)

4. prosince 2007

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

12. dubna 2011

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. dubna 2011

Naposledy ověřeno

1. dubna 2011

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • M10-238

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