A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)

PHASE3CompletedINTERVENTIONAL
Enrollment

385

Participants

Timeline

Start Date

September 27, 2018

Primary Completion Date

April 1, 2021

Study Completion Date

November 2, 2021

Conditions
Rheumatoid Arthritis (RA)
Interventions
DRUG

Peficitinib

Oral

DRUG

Plaebo

Oral

DRUG

Disease-modifying antirheumatic drugs (DMARDs)

"As necessary concomitant medications, DMARDs listed below will be administered orally unless specified.~For subjects who are inadequate responders to methotrexate (MTX): MTX. For subjects who are intolerant of MTX: either of DMARDs listed; hydroxychloroquine, salazosulfapyridine, gold (injection or oral), D-penicillamine, lobenzarit, actarit, bucillamine and iguratimod."

Trial Locations (43)

Unknown

Site CN00048, Anhui

Site CN00045, Beijing

Site CN00054, Beijing

Site CN00050, Bengbu

Site CN00061, Changchun

Site CN00032, Changsha

Site CN00076, Chenzhou

Site CN00071, Guangdong

Site CN00016, Guangzhou

Site CN00052, Guangzhou

Site CN00063, Guangzhou

Site CN00072, Guangzhou

Site CN00058, Inner Mongolia

Site CN00074, Jieyang

Site CN00028, Jilin

Site CN00069, Jining

Site CN00064, Jiujiang

Site CN00046, Kunming

Site CN00060, Nanjing

Site CN00070, Nanjing

Site CN00068, Ningbo

Site CN00075, Pingxiang

Site CN00066, Qingdao

Site CN00056, Shanghai

Site CN00047, Shantou

Site CN00053, Sichuan

Site CN00057, Tianjin

Site CN00062, Tianjin

Site CN00059, Wuhan

Site CN00067, Xining

Site CN00065, Xuzhou

Site CN00073, Zhengzhou

Site CN00049, Zhuzhou

Site KR00037, Gwangju

Site KR00036, Incheon

Site KR00033, Seoul

Site KR00034, Seoul

Site KR00035, Seoul

Site TW00022, Taichung

Site TW00023, Taichung

Site TW00024, Taichung

Site TW00025, Taipei

Site TW00026, Taipei

All Listed Sponsors
lead

Astellas Pharma China, Inc.

INDUSTRY

NCT03660059 - A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX) | Biotech Hunter | Biotech Hunter