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Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
adalimumab
methotrexate
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, adalimumab

Eligibility Criteria

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

Inclusion Criteria: Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9 tender joints Subjects must have received at least one prior DMARD besides MTX, but may have had efficacy failures on no more than four standard DMARDs other than MTX Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTX for at least 4 weeks prior to screening visit Age 18 years and older Exclusion Criteria: Prior treatment with any TNF antagonist, including adalimumab History of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin. Subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-CD4 antibody, within 6 months prior to the screening evaluation, prior treatment with any TNF antagonist, including Adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide. Chest X-ray with calcified granuloma and/or pleural scarring Positive TB skin test, RT23 dose skin test, >5 mm at 48 to 72 hours Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation Female who is pregnant or breast-feeding.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    ACR20

    Secondary Outcome Measures

    Safety parameters

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    August 28, 2007
    Sponsor
    Abbott
    Collaborators
    Eisai Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00235859
    Brief Title
    Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott
    Collaborators
    Eisai Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    adalimumab
    Intervention Type
    Drug
    Intervention Name(s)
    methotrexate
    Primary Outcome Measure Information:
    Title
    ACR20
    Secondary Outcome Measure Information:
    Title
    Safety parameters

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9 tender joints Subjects must have received at least one prior DMARD besides MTX, but may have had efficacy failures on no more than four standard DMARDs other than MTX Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTX for at least 4 weeks prior to screening visit Age 18 years and older Exclusion Criteria: Prior treatment with any TNF antagonist, including adalimumab History of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin. Subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-CD4 antibody, within 6 months prior to the screening evaluation, prior treatment with any TNF antagonist, including Adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide. Chest X-ray with calcified granuloma and/or pleural scarring Positive TB skin test, RT23 dose skin test, >5 mm at 48 to 72 hours Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation Female who is pregnant or breast-feeding.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beverly Paperiello
    Organizational Affiliation
    Abbott
    Official's Role
    Study Director

    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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    Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

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