Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Study Identifier
M05-775
CT.gov Identifier
NCT00603993
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • Adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    20+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Completed Week 36 of Study M03-651 [NCT 00235872] - Wish to participate in self-injection study - Give written informed consent - Comply with protocol requirements
    Exclusion Criteria:
    - Subject develops serious adverse events at time of eligibility confirmation - Subject develops severe infections requiring hospitalization or IV injection of antibiotics within 28 days before eligibility confirmation - Subject develops infections requiring oral administration of antibiotics within 14 days before eligibility confirmation - The investigator considers the subject inappropriate for participation

    Protocol Summary

    The purpose of this study is to evaluate the long-term safety of subcutaneous (SC)

    self-injections (by the subject or subject's family member) of adalimumab in adult Japanese

    subjects with Rheumatoid Arthritis in an open-label study.

    Study Locations

    Location
    Status
    Location
    Aichi, Japan
    Status
    Not applicable
    Location
    Chiba, Japan
    Status
    Not applicable
    Location
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Gunma, Japan
    Status
    Not applicable
    Location
    Hokkaido, Japan
    Status
    Not applicable
    Location
    Hyogo, Japan
    Status
    Not applicable
    Showing {first} - {last} of {total} Results