A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

334

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

August 31, 2011

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

Double-blind adalimumab

Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)

DRUG

Double-blind Placebo

Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)

BIOLOGICAL

Open-label Adalimumab

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study

BIOLOGICAL

Open-labelAdalimumabRescue

Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26

Trial Locations (88)

Unknown

Site Reference ID/Investigator# 46861, Anjo

Site Reference ID/Investigator# 46919, Aomori

Site Reference ID/Investigator# 46805, Chiba

Site Reference ID/Investigator# 46806, Chiba

Site Reference ID/Investigator# 46880, Chiba

Site Reference ID/Investigator# 46881, Chiba

Site Reference ID/Investigator# 46890, Fuchū

Site Reference ID/Investigator# 46902, Fukuoka

Site Reference ID/Investigator# 46903, Fukuoka

Site Reference ID/Investigator# 46904, Fukuoka

Site Reference ID/Investigator# 46856, Gifu

Site Reference ID/Investigator# 46944, Gunma

Site Reference ID/Investigator# 46893, Hiroshima

Site Reference ID/Investigator# 46894, Hiroshima

Site Reference ID/Investigator# 12161, Hokkaido

Site Reference ID/Investigator# 46916, Hokkaido

Site Reference ID/Investigator# 46918, Hokkaido

Site Reference ID/Investigator# 46865, Hyōgo

Site Reference ID/Investigator# 46871, Hyōgo

Site Reference ID/Investigator# 46801, Ibaraki

Site Reference ID/Investigator# 46925, Ibaraki

Site Reference ID/Investigator# 46873, Kagoshima

Site Reference ID/Investigator# 46874, Kagoshima

Site Reference ID/Investigator# 46845, Kanagawa

Site Reference ID/Investigator# 46899, Kanagawa

Site Reference ID/Investigator# 46901, Kanagawa

Site Reference ID/Investigator# 46851, Kanazawa

Site Reference ID/Investigator# 46852, Kanazawa

Site Reference ID/Investigator# 46802, Kawagoe

Site Reference ID/Investigator# 46900, Kawasaki

Site Reference ID/Investigator# 46875, Kirishima

Site Reference ID/Investigator# 46870, Kitakyushu

Site Reference ID/Investigator# 46872, Kumamoto

Site Reference ID/Investigator# 46912, Kumamoto

Site Reference ID/Investigator# 46864, Kyoto

Site Reference ID/Investigator# 46943, Maebashi

Site Reference ID/Investigator# 46898, Matsuyama

Site Reference ID/Investigator# 46915, Miyazaki

Site Reference ID/Investigator# 46853, Nagano

Site Reference ID/Investigator# 46855, Nagano

Site Reference ID/Investigator# 46909, Nagasaki

Site Reference ID/Investigator# 46910, Nagasaki

Site Reference ID/Investigator# 46911, Nagasaki

Site Reference ID/Investigator# 46858, Nagoya

Site Reference ID/Investigator# 46860, Nagoya

Site Reference ID/Investigator# 46877, Nara

Site Reference ID/Investigator# 46885, Nara

Site Reference ID/Investigator# 46848, Niigata

Site Reference ID/Investigator# 46906, Niigata

Site Reference ID/Investigator# 46800, Numakunai

Site Reference ID/Investigator# 46869, Okayama

Site Reference ID/Investigator# 46886, Okayama

Site Reference ID/Investigator# 46887, Okayama

Site Reference ID/Investigator# 46892, Okayama

Site Reference ID/Investigator# 46876, Okinawa

Site Reference ID/Investigator# 46946, Osaka

Site Reference ID/Investigator# 46947, Osaka

Site Reference ID/Investigator# 46914, Ōita

Site Reference ID/Investigator# 46842, Rifu

Site Reference ID/Investigator# 46846, Sagamihara

Site Reference ID/Investigator# 46803, Saitama

Site Reference ID/Investigator# 46804, Saitama

Site Reference ID/Investigator# 46878, Saitama

Site Reference ID/Investigator# 46879, Saitama

Site Reference ID/Investigator# 46917, Sapporo

Site Reference ID/Investigator# 46942, Shimotsuke

Site Reference ID/Investigator# 46854, Shizuoka

Site Reference ID/Investigator# 46857, Shizuoka

Site Reference ID/Investigator# 46859, Shizuoka

Site Reference ID/Investigator# 46895, Takamatsu

Site Reference ID/Investigator# 46843, Tokyo

Site Reference ID/Investigator# 46844, Tokyo

Site Reference ID/Investigator# 46850, Tokyo

Site Reference ID/Investigator# 46882, Tokyo

Site Reference ID/Investigator# 46883, Tokyo

Site Reference ID/Investigator# 46884, Tokyo

Site Reference ID/Investigator# 46888, Tokyo

Site Reference ID/Investigator# 46889, Tokyo

Site Reference ID/Investigator# 46891, Tokyo

Site Reference ID/Investigator# 46896, Tokyo

Site Reference ID/Investigator# 46849, Toyama

Site Reference ID/Investigator# 46907, Toyama

Site Reference ID/Investigator# 46862, Toyoake

Site Reference ID/Investigator# 46866, Toyohashi

Site Reference ID/Investigator# 46863, Tsu

Site Reference ID/Investigator# 46926, Tsukuba

Site Reference ID/Investigator# 46897, Yokohama

Site Reference ID/Investigator# 46905, Yokohama

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eisai Co., Ltd.

INDUSTRY

lead

Abbott

INDUSTRY

NCT00870467 - A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter