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 December 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01638013
First received: July 9, 2012
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • Percentage of Subjects achieving ACR 50 response [ Time Frame: At each study visit to the end of the study (Sept 2018) ] [ Designated as safety issue: No ]
  • Percentage of Subjects achieving ACR 70 response [ Time Frame: At each study visit to the end of the study (Sept 2018) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • Subject has developed an adverse reaction to the study drug in studies RAJ1, RAJ3 or RAJ4, and the risks of continuing treatment with this drug are expected to outweigh the benefits
  • 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)
  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 ClinicalTrials.gov identifier: NCT01638013

Contacts
Contact: Clinical Development Administration Dept. Astellas.registration@astellas.com

Locations
Japan
Recruiting
Chubu, Japan
Recruiting
Chugoku, Japan
Recruiting
Hokkaido, Japan
Recruiting
Kansai, Japan
Recruiting
Kantou, Japan
Recruiting
Kyushu, Japan
Recruiting
Touhoko, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01638013     History of Changes
Other Study ID Numbers: 015K-CL-RAJ2
Study First Received: July 9, 2012
Last Updated: December 4, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis
ASP015K

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 26, 2015