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Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab (PROWD)

Primary Purpose

Rheumatoid Arthritis

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Males and females >= 18 years of age
  • ACR criteria for RA diagnosis for at least 6 months
  • Active RA defined as a DAS 28 >3.2 at study entry
  • Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
  • A negative pregnancy test for females of childbearing potential

Exclusion Criteria:

  • Patient who had previous treatment with cyclophosphamide and chlorambucil
  • Treatment within the last 8 weeks with infliximab
  • Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
  • Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
  • History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
  • Prior treatment with total lymphoid irradiation

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2008
    Last Updated
    March 28, 2008
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00650390
    Brief Title
    Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
    Acronym
    PROWD
    Official Title
    Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    5. Study Description

    Brief Summary
    The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.

    6. Conditions and Keywords

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

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    adalimumab
    Other Intervention Name(s)
    ABT-D2E7, Humira
    Intervention Description
    40 mg adalimumab every other week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Males and females >= 18 years of age ACR criteria for RA diagnosis for at least 6 months Active RA defined as a DAS 28 >3.2 at study entry Unsatisfactory response, loss of response or intolerance to prior infliximab treatment A negative pregnancy test for females of childbearing potential Exclusion Criteria: Patient who had previous treatment with cyclophosphamide and chlorambucil Treatment within the last 8 weeks with infliximab Prior treatment with more than one DMARD or DMARD combination following infliximab treatment Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease Prior treatment with total lymphoid irradiation

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27338778
    Citation
    Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
    Results Reference
    derived

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    Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

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