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

8 april 2011 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

152

Fase

  • Fase 3

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

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

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:

  • 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

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: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Etiket openen
Biologisch: 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.
Andere namen:
  • ABT-D2E7
  • Humira

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants Achieving a PGA of Clear (0) at Week 16
Tijdsspanne: Week 16
Week 16
Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Abbott

Onderzoekers

  • Studie directeur: Martin M Okun, M.D., Ph.D., 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

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 januari 2008

Primaire voltooiing (Werkelijk)

1 april 2009

Studie voltooiing (Werkelijk)

1 april 2009

Studieregistratiedata

Eerst ingediend

1 december 2007

Eerst ingediend dat voldeed aan de QC-criteria

1 december 2007

Eerst geplaatst (Schatting)

4 december 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

12 april 2011

Laatste update ingediend die voldeed aan QC-criteria

8 april 2011

Laatst geverifieerd

1 april 2011

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • M10-238

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 .

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