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Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis (CanAct)

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:

  • Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12
  • Patients 18 years of age or older
  • Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control
  • Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab

  • Diagnosis of active RA defined by >= 5 swollen joints and one of the following:

    • Positive RF
    • One or more joint erosions present of x-ray
    • HAQ score > 1

Exclusion Criteria:

  • Patient has failed 2 or more biologics
  • Patient who had previous treatment with cyclophosphamide and chlorambucil
  • Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +< 500/mm3)
  • History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
  • History of malignant lymphoma or leukemia regardless of treatment

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 27, 2008
    Last Updated
    March 31, 2008
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00649545
    Brief Title
    Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis
    Acronym
    CanAct
    Official Title
    A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis
    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 primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).

    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 every other week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12 Patients 18 years of age or older Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab Diagnosis of active RA defined by >= 5 swollen joints and one of the following: Positive RF One or more joint erosions present of x-ray HAQ score > 1 Exclusion Criteria: Patient has failed 2 or more biologics Patient who had previous treatment with cyclophosphamide and chlorambucil Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +< 500/mm3) History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix History of malignant lymphoma or leukemia regardless of treatment

    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
    PubMed Identifier
    22093579
    Citation
    Haraoui B, Cividino A, Stewart J, Guerette B, Keystone EC. Safety and effectiveness of adalimumab in a clinical setting that reflects Canadian standard of care for the treatment of rheumatoid arthritis (RA): results from the CanACT study. BMC Musculoskelet Disord. 2011 Nov 17;12:261. doi: 10.1186/1471-2474-12-261.
    Results Reference
    derived

    Learn more about this trial

    Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

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