A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Abatacept

Vials (250 mg/vial), Intravenous, Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit; 500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1,000 mg for participants \> 100 kg, administered over a period of approximately 30 minutes at week 0, 2, 4 and every 4 weeks thereafter, until approved in Japan and was continued as a post-marketing study until the completion of the shift to a commercially available product.

Trial Locations (39)

3290498

Local Institution, Shimotsuke-Shi

9100067

Local Institution, Fukui-shi

9103133

Local Institution, Fukui-shi

460-0001

Local Institution, Nagoya

466-8550

Local Institution, Nagoya

037-0053

Local Institution, Goshogawara-Shi

Unknown

Local Institution, Chiba

Local Institution, Sendai

910-0041

Local Institution, Fukui-shi

810-0065

Local Institution, Fukuoka

812-0025

Local Institution, Fukuoka

807-8555

Local Institution, Kitakyushu-Shi

739-0002

Local Institution, Higashi-Hiroshima-Shi

060-0001

Local Institution, Sapporo

060-8604

Local Institution, Sapporo

060-8648

Local Institution, Sapporo

679-2414

Local Institution, Kanzaki-Gun

673-1462

Local Institution, Kato-Gun

316-0035

Local Institution, Hitachi-Shi

305-0005

Local Institution, Tsukuba

228-8522

Local Institution, Sagamihara-Shi

981-0911

Local Institution, Sendai

982-0032

Local Institution, Sendai

380-8582

Local Institution, Nagano

701-0304

Local Institution, Tsukubo-Gun

86-0008

Local Institution, Kawachinagano-Shi

843-0301

Local Institution, Ureshino-Shi

350-0495

Local Institution, Iruma-Gun

350-8550

Local Institution, Kawagoe-Shi

364-0026

Local Institution, Kitamoto-Shi

430-0906

Local Institution, Hamamatsu

329-1104

Local Institution, Kawachigun

116-0011

Local Institution, Arakawa-Ku

113-0022

Local Institution, Bunkyo-Ku

113-8519

Local Institution, Bunkyo-Ku

155-0032

Local Institution, Setagaya-Ku

162-0054

Local Institution, Shinjuku-Ku

933-8525

Local Institution, Takaoka-Shi

260-0801

Local Institution, Chiba

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY