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

8 de abril de 2011 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Real)

152

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Rótulo aberto
Biológico: 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.
Outros nomes:
  • ABT-D2E7
  • Humira

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Achieving a PGA of Clear (0) at Week 16
Prazo: Week 16
Week 16
Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Abbott

Investigadores

  • Diretor de estudo: Martin M Okun, M.D., Ph.D., Abbott

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2008

Conclusão Primária (Real)

1 de abril de 2009

Conclusão do estudo (Real)

1 de abril de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

1 de dezembro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de dezembro de 2007

Primeira postagem (Estimativa)

4 de dezembro de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

12 de abril de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de abril de 2011

Última verificação

1 de abril de 2011

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • M10-238

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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