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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)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03660059

Astellas Study ID

The unique identification code given by the study sponsor.

015K-CL-CNA3

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

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Condition

Rheumatoid Arthritis

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 years - N/A

Sex

Female & Male

Product

peficitinib hydrobromide

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Sep 2018 - Nov 2021

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

385

A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients with Rheumatoid Arthritis (RA) who Had an Inadequate Response or Intolerance to MTX

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

Get More Information

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Locations

Site CN00069

Jining, China

Site CN00067

Xining, China

Site TW00025

Taipei, Taiwan, Province of China

Site CN00071

Guangdong, China

Site TW00026

Taipei, Taiwan, Province of China

Site CN00062

Tianjin, China

Site CN00053

Sichuan, China

Site CN00076

Chenzhou, China

Site CN00065

Xuzhou, China

Site CN00016

Guangzhou, China

Site KR00036

Incheon, Republic of Korea

Site CN00046

Kunming, China

Site CN00050

Bengbu, China

Site KR00037

Gwangju, Republic of Korea

Site CN00057

Tianjin, China

Site CN00070

Nanjing, China

Site KR00035

Seoul, Republic of Korea

Site CN00059

Wuhan, China

Site TW00022

Taichung, Taiwan, Province of China

Site CN00049

Zhuzhou, China

Site CN00061

Changchun, China

Site KR00034

Seoul, Republic of Korea

Site CN00052

Guangzhou, China

Site CN00074

Jieyang, China

Site CN00054

Beijing, China

Site CN00063

Guangzhou, China

Site CN00068

Ningbo, China

Site KR00033

Seoul, Republic of Korea

Site CN00075

Pingxiang, China

Site CN00073

Zhengzhou, China

Site TW00024

Taichung, Taiwan, Province of China

Site CN00028

Jilin, China

Site TW00023

Taichung, Taiwan, Province of China

Site CN00072

Guangzhou, China

Site CN00045

Beijing, China

Site CN00066

Qingdao, China

Site CN00058

Inner Mongolia, China

Site CN00032

Changsha, China

Site CN00047

Shantou, China

Site CN00064

Jiujiang, China

Site CN00056

Shanghai, China

Site CN00048

Anhui, China

Site CN00060

Nanjing, China

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