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
Study Drug
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