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A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: July 9, 2012
Last updated: April 19, 2017
Last verified: April 2017
The purpose of this study is to evaluate the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.

Condition Intervention Phase
Arthritis, Rheumatoid
Drug: ASP015K
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Extension Study of ASP015K - Open-Label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase IIb Study or Phase III Study of ASP015K

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs, chest radiography and lab-tests [ Time Frame: To the end of the study (Sept 2018) ]

Secondary Outcome Measures:
  • Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response [ Time Frame: At each study visit to the end of the study (Sept 2018) ]
  • Percentage of Subjects achieving ACR 50 response [ Time Frame: At each study visit to the end of the study (Sept 2018) ]
  • Percentage of Subjects achieving ACR 70 response [ Time Frame: At each study visit to the end of the study (Sept 2018) ]
  • Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) [ Time Frame: At each study visit to the end of the study (Sept 2018) ]

Estimated Enrollment: 800
Actual Study Start Date: June 13, 2012
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP015K group
Drug: ASP015K

Detailed Description:

This study is an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) patients who completed the Phase IIb Study of ASP015K [015K-CL-RAJ1 (hereinafter referred to as study RAJ1)], Phase III Study of ASP015K [015K-CL-RAJ3 (RAJ3)], or Phase III Study of ASP015K [015K-CL-RAJ4 (RAJ4)].

Patients will receive oral ASP015K once daily (QD) after breakfast. The ASP015K dose can be increased later if the subjects have no safety problems but show lack of efficacy.

The duration of treatment with the study drug will differ depending upon the subject.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol
  • The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate

Exclusion Criteria:

  • There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected
  • Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
  • Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it
  • Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy)
  • Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01638013

Contact: Clinical Development Administration Dept.

Site JP00001 Recruiting
Chubu, Japan
Site JP00002 Recruiting
Chugoku, Japan
Site JP00003 Recruiting
Hokkaido, Japan
Site JP00004 Recruiting
Kansai, Japan
Site JP00005 Recruiting
Kantou, Japan
Site JP00006 Recruiting
Kyushu, Japan
Site JP00007 Recruiting
Touhoku, Japan
Korea, Republic of
Site KR00001 Recruiting
Daegu, Korea, Republic of
Site KR00002 Recruiting
Gwangju, Korea, Republic of
Site KR00003 Recruiting
Incheon, Korea, Republic of
Site KR00004 Recruiting
Jeonju-si, Korea, Republic of
Site KR00005 Recruiting
Seoul, Korea, Republic of
Site KR00006 Recruiting
Suwon-si, Korea, Republic of
Site TW00001 Recruiting
Kaohsiung, Taiwan
Site TW00002 Recruiting
Taichung, Taiwan
Site TW00003 Recruiting
Tainan, Taiwan
Site TW00004 Recruiting
Taipei, Taiwan
Site TW00005 Recruiting
Taoyuan, Taiwan
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Medical Director Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc Identifier: NCT01638013     History of Changes
Other Study ID Numbers: 015K-CL-RAJ2
Study First Received: July 9, 2012
Last Updated: April 19, 2017

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on May 23, 2017