A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab

Study Identifier
M11-964
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Rheumatoid Arthritis
  • Study Drug
  • Adalimumab
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The study is being conducted in three countries, Australia (3 sites), Canada (2 sites), and Germany (2 sites).

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 63354
    Malvern East, Australia, 3145
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63355
    Maroochydore, Australia, 4558
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63353
    Shenton Park, Australia, 6008
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 67105
    Hamilton, Canada, L8N 2B6
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 64122
    Winnipeg, Canada, R3A 1M3
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63356
    Munich, Germany, 80336
    Status
    Not applicable
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