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A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed 015K-CL-RAJ1 Study

This study is currently recruiting participants.
Verified August 2012 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01638013
First received: July 9, 2012
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of long-term administration of ASP015K in patients who completed the 15K-CL-RAJ1 study.


Condition Intervention Phase
Arthritis, Rheumatoid
 Drug: ASP015K
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase IIb Extension Study of ASP015K - Open-Label Extension Study in RA Patients Who Have Completed Phase IIb Study of ASP015K -

Resource links provided by NLM:

U.S. FDA Resources

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 and labo-tests [ Time Frame: To the end of the study (up to 132 weeks) ] [ 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 (up to 132 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Subjects achieving ACR 50 response [ Time Frame: At each study visit (up to 132 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Subjects achieving ACR 70 response [ Time Frame: At each study visit (up to 132 weeks) ] [ 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 (up to 132 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP015K group Drug: ASP015K
oral

Detailed Description:

This study is an extension of study RAJ1 conducted as an open-label multicenter study in RA patients who completed study RAJ1.

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 dose level will be reconsidered after the results of the dose-setting study (study RAJ1) have been obtained.

Because this study will end at the point in time where the Phase III study begins, the duration of treatment with the study drug will differ depending upon the subject (planned maximum duration of treatment: 132 weeks).

  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 study RAJ1as 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 study RAJ1 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)

  • Subject has taken one of the following drugs between the end of the assessments at Week 12 of study RAJ1 and the start of treatment with the study drug in this Extension Study.

    • Biologic DMARD (biologic for the treatment of RA): Etanercept, adalimumab, golimumab, infliximab, tocilizumab, abatacept, rituximab
    • Non-biologic DMARD: Methotrexate, salazosulfapyridine, gold, D-penicillamine, leflunomide, lobenzarit, actarit, tacrolimus, mizorinbine, bucillamine (However, topical drugs other than those for the treatment of RA may be used.)
    • Other drugs used in the treatment of RA: Cyclosporine
  • Subject has received plasma exchange therapy between the end of the assessments at Week 12 of study RAJ1 and the start of treatment with the study drug in this Extension Study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638013

Contacts
Contact: Clinical Development Administration Dept. clinicaltrials_info@jp.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: August 28, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 23, 2013