NCT03028467View on ClinicalTrials.gov

Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 24, 2017

Primary Completion Date

December 20, 2017

Study Completion Date

December 20, 2017

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

GSK3196165 Dose 1

GSK3196165 is supplied as liquid and will be administered as SC injection.

DRUG

GSK3196165 Dose 2

GSK3196165 is supplied as liquid and will be administered as SC injection.

DRUG

GSK3196165 Dose 3

GSK3196165 is supplied as liquid and will be administered as SC injection.

DRUG

Methotrexate

Methotrexate capsule/tablet 8-16 mg per week is given orally.

DRUG

Placebo

Placebo is supplied as liquid as sterile 0.9% sodium chloride solution and will be administered as SC injection.

DRUG

Folic acid

Folic acid tablet 5 mg per week is given orally.

Trial Locations (32)

440-8510

GSK Investigational Site, Aichi

440-85

GSK Investigational Site, Aichi

455-8530

GSK Investigational Site, Aichi

455-85

GSK Investigational Site, Aichi

457-8511

GSK Investigational Site, Aichi

457-85

GSK Investigational Site, Aichi

260-8712

GSK Investigational Site, Chiba

260-87

GSK Investigational Site, Chiba

270-2296

GSK Investigational Site, Chiba

270-22

GSK Investigational Site, Chiba

810-8563

GSK Investigational Site, Fukuoka

810-85

GSK Investigational Site, Fukuoka

814-0180

GSK Investigational Site, Fukuoka

814-01

GSK Investigational Site, Fukuoka

665-0827

GSK Investigational Site, Hyōgo

665-08

GSK Investigational Site, Hyōgo

673-1462

GSK Investigational Site, Hyōgo

673-14

GSK Investigational Site, Hyōgo

312-0057

GSK Investigational Site, Ibaraki

312-00

GSK Investigational Site, Ibaraki

222-0036

GSK Investigational Site, Kanagawa

240-8521

GSK Investigational Site, Kanagawa

240-85

GSK Investigational Site, Kanagawa

245-8575

GSK Investigational Site, Kanagawa

245-85

GSK Investigational Site, Kanagawa

857-1195

GSK Investigational Site, Nagasaki

857-11

GSK Investigational Site, Nagasaki

543-8555

GSK Investigational Site, Osaka

543-85

GSK Investigational Site, Osaka

586-8521

GSK Investigational Site, Osaka

649-2211

GSK Investigational Site, Wakayama

649-22

GSK Investigational Site, Wakayama

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03028467 - Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter