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Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Primary Purpose

Arthritis, Psoriatic

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

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Moderate to severe PsA
  • Inadequate response to DMARD therapy
  • Corticosteroid stable dose <= 10 mg QD
  • DMARDs must have been taken for 3 months and stable dose for 4 weeks
  • MTX maximum dose = <= 30 mg/week
  • Active chronic plaque PS or documented history of chronic plaque PS

Exclusion Criteria:

  • No other active skin disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    A

    B

    Arm Description

    Outcomes

    Primary Outcome Measures

    ACR20
    Adverse Events
    Sharp Score

    Secondary Outcome Measures

    ACR20, 50, 70
    Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI

    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
    NCT00646386
    Brief Title
    Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
    Official Title
    Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    5. Study Description

    Brief Summary
    Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Title
    B
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    adalimumab
    Other Intervention Name(s)
    ABT-D2E7, Humira
    Intervention Description
    40 mg eow Week 0 - Week 24
    Intervention Type
    Drug
    Intervention Name(s)
    placebo for adalimumab
    Other Intervention Name(s)
    placebo
    Intervention Description
    40 mg eow Week 0 - Week 24
    Primary Outcome Measure Information:
    Title
    ACR20
    Time Frame
    Week 12
    Title
    Adverse Events
    Time Frame
    Throughout study participation
    Title
    Sharp Score
    Time Frame
    Week 24
    Secondary Outcome Measure Information:
    Title
    ACR20, 50, 70
    Time Frame
    Weeks 12, 24
    Title
    Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI
    Time Frame
    Weeks 12 and 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Moderate to severe PsA Inadequate response to DMARD therapy Corticosteroid stable dose <= 10 mg QD DMARDs must have been taken for 3 months and stable dose for 4 weeks MTX maximum dose = <= 30 mg/week Active chronic plaque PS or documented history of chronic plaque PS Exclusion Criteria: No other active skin disease

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30608620
    Citation
    Landewe R, Ritchlin CT, Aletaha D, Zhang Y, Ganz F, Hojnik M, Coates LC. Inhibition of radiographic progression in psoriatic arthritis by adalimumab independent of the control of clinical disease activity. Rheumatology (Oxford). 2019 Jun 1;58(6):1025-1033. doi: 10.1093/rheumatology/key417.
    Results Reference
    derived
    PubMed Identifier
    23504383
    Citation
    Mease PJ, Heckaman M, Kary S, Kupper H. Application and modifications of minimal disease activity measures for patients with psoriatic arthritis treated with adalimumab: subanalyses of ADEPT. J Rheumatol. 2013 May;40(5):647-52. doi: 10.3899/jrheum.120970. Epub 2013 Mar 15.
    Results Reference
    derived

    Learn more about this trial

    Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

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