Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.

Study Identifier
M12-783
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 two countries, Belgium (3 sites) and the Czech Republic (3 sites).

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 63357
    Genk, Belgium, 3600
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63359
    Ghent, Belgium, 9000
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63360
    Ghent, Belgium, 9000
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63363
    Brno, Czech Republic, 63800
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63362
    Prague, Czech Republic, 128 50
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 63361
    Uherské Hradiště, Czech Republic, 686 01
    Status
    Not applicable