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Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
adalimumab
adalimumab
adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject completed prior PS study

Exclusion Criteria:

  • Subject has other active skin diseases
  • Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
  • Poorly controlled medical conditions
  • History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
  • History of cancer or lymphoproliferative disease
  • History of active TB or listeriosis, or persistent chronic or active infections
  • Known to have immune deficiency or is immunocompromised
  • Clinically significant abnormal laboratory test results
  • Erythrodermic psoriasis or generalized pustular psoriasis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    A

    B

    C

    Arm Description

    Outcomes

    Primary Outcome Measures

    Psoriasis Area and Severity Index
    Adverse Events

    Secondary Outcome Measures

    Psoriasis Area and Severity Index
    DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS
    Physician's Global Assessment

    Full Information

    First Posted
    March 26, 2008
    Last Updated
    March 26, 2008
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00646191
    Brief Title
    Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
    Official Title
    Multicenter Extension Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    June 2004 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    137 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Title
    C
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    adalimumab
    Other Intervention Name(s)
    ABT-D2E7, Humira
    Intervention Description
    40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
    Intervention Type
    Drug
    Intervention Name(s)
    adalimumab
    Other Intervention Name(s)
    ABT-D2E7, Humira
    Intervention Description
    40 mg weekly through Week 48 (OL Week 12 - 48)
    Intervention Type
    Drug
    Intervention Name(s)
    adalimumab
    Other Intervention Name(s)
    ABT-D2E7, Humira
    Intervention Description
    80 mg W0, 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
    Primary Outcome Measure Information:
    Title
    Psoriasis Area and Severity Index
    Time Frame
    Week 12
    Title
    Adverse Events
    Time Frame
    Throughout Study Participation
    Secondary Outcome Measure Information:
    Title
    Psoriasis Area and Severity Index
    Time Frame
    Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48
    Title
    DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS
    Time Frame
    Week 12, 24 and 48
    Title
    Physician's Global Assessment
    Time Frame
    Week 12, 16, 20, 24, 32, 40 and 48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject completed prior PS study Exclusion Criteria: Subject has other active skin diseases Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) Poorly controlled medical conditions History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease History of cancer or lymphoproliferative disease History of active TB or listeriosis, or persistent chronic or active infections Known to have immune deficiency or is immunocompromised Clinically significant abnormal laboratory test results Erythrodermic psoriasis or generalized pustular psoriasis

    12. IPD Sharing Statement

    Learn more about this trial

    Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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