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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

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ClinicalTrials.gov Identifier: NCT01638013
Recruitment Status : Active, not recruiting
First Posted : July 11, 2012
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: peficitinib Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 844 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : June 13, 2012
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ASP015K group
oral
Drug: peficitinib
oral
Other Name: ASP015K



Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. Percentage of Subjects achieving ACR 50 response [ Time Frame: At each study visit to the end of the study (Sept 2018) ]
  3. Percentage of Subjects achieving ACR 70 response [ Time Frame: At each study visit to the end of the study (Sept 2018) ]
  4. 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) ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638013


  Show 175 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01638013     History of Changes
Other Study ID Numbers: 015K-CL-RAJ2
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis
ASP015K

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