171
Participants
Start Date
September 30, 2002
Primary Completion Date
January 31, 2005
Study Completion Date
June 30, 2010
Double-Blind Adalimumab/Placebo + MTX
Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg.
Double-Blind Adalimumab/Placebo
Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg.
OLE BSA Adalimumab +/- MTX
Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase.
OLE FD Adalimumab +/- MTX
Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase.
Site Reference ID/Investigator# 2538, Leuven
Site Reference ID/Investigator# 621, Ghent
Site Ref # / Investigator 45542, New Hyde Park
Site Reference ID/Investigator# 627, Berlin
Site Reference ID/Investigator# 45545, Marseille
Site Reference ID/Investigator# 631, Genoa
Site Reference ID/Investigator# 636, Milan
Site Reference ID/Investigator# 622, Hamburg
Site Reference ID/Investigator# 406, Norfolk
Site Reference ID/Investigator# 3713, Madrid
Site Reference ID/Investigator# 638, Delray Beach
Site Ref # / Investigator 45543, St. Petersburg
Site Reference ID/Investigator# 386, Columbus
Site Reference ID/Investigator# 641, Minneapolis
Site Reference ID/Investigator# 640, Chicago
Site Reference ID/Investigator# 644, Kansas City
Site Reference ID/Investigator# 645, Omaha
Site Reference ID/Investigator# 516, Paris
Site Ref # / Investigator 45522, Garmisch-Partenkirchen
Site Reference ID/Investigator# 2235, Los Angeles
Site Reference ID/Investigator# 642, Stanford
Site Ref # / Investigator 45524, Birmingham
Site Reference ID/Investigator# 2501, Livingston
Site Ref # / Investigator 45544, Chapel Hill
Site Ref # / Investigator 45525, Salt Lake City
Site Reference ID/Investigator# 519, Prague
Site Reference ID/Investigator# 518, Prague
Site Reference ID/Investigator# 625, Bremen
Site Reference ID/Investigator# 628, Halle
Site Ref # / Investigator 45523, Košice
Site Reference ID/Investigator# 3425, Piešťany
Lead Sponsor
Abbott
INDUSTRY