A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01649999
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : August 23, 2017
Information provided by (Responsible Party):
Astellas Pharma Inc

July 23, 2012
July 25, 2012
August 23, 2017
March 1, 2012
July 1, 2013   (Final data collection date for primary outcome measure)
Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response [ Time Frame: Week 12 ]
Same as current
Complete list of historical versions of study NCT01649999 on Archive Site
  • Percentage of Subjects achieving ACR 50 response [ Time Frame: Week 12 ]
  • Percentage of Subjects achieving ACR 70 response [ Time Frame: Week 12 ]
  • Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) [ Time Frame: Baseline and Week 12 ]
  • Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and clinical labo-tests [ Time Frame: During 12-week treatment period and 4-week follow-up period ]
Same as current
Not Provided
Not Provided
A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects
A Phase 2b Study of ASP015K -Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Subjects -
This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects given ASP015K for 12 weeks.

This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, dose-finding, monotherapy, multi-center study with once daily oral ASP015K or matching placebo in subjects with moderate to severe RA, with or without prior antirheumatic medication, and regardless of responsiveness to the medication.

The study is comprised of up to a 4-week Screening period, a 12-week Treatment period and a 4-week Follow-up period.

Subjects in each treatment group will take ASP015K or matching placebo orally, once daily, after breakfast for 12 weeks after the screening period.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: ASP015K
  • Drug: Placebo
  • Experimental: ASP015K lowest dose
    Intervention: Drug: ASP015K
  • Experimental: ASP015K low dose
    Intervention: Drug: ASP015K
  • Experimental: ASP015K medium dose
    Intervention: Drug: ASP015K
  • Experimental: ASP015K high dose
    Intervention: Drug: ASP015K
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Takeuchi T, Tanaka Y, Iwasaki M, Ishikura H, Saeki S, Kaneko Y. Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study. Ann Rheum Dis. 2016 Jun;75(6):1057-64. doi: 10.1136/annrheumdis-2015-208279. Epub 2015 Dec 15.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 1, 2013
July 1, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has received a full explanation of the study drug and this study in advance, and written informed consent to participate in the study has been obtained from the subject himself/herself
  • Outpatient has RA that was diagnosed according to the 1987 revised criteria of the ACR at least 6 months prior to screening
  • At screening subject has active RA as evidenced by all of the following:

    • ≥ 6 tender/painful joints;
    • ≥ 6 swollen joints;
    • CRP of ≥ 0.5 mg/dL or ESR of ≥ 28 mm/h.C-Reactive Protein (CRP) of ≥ 0.8 mg/dL or Erythrocyte Sedimentation Rate (ESR) of ≥ 28 mm/hr
  • Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA, Class I, II or, III at screening

Exclusion Criteria:

  • Positive tuberculin (TB) test within 90 days of Screening
  • Abnormal chest x-ray indicative of an acute or chronic infectious process or malignancy
  • Receipt of live or live attenuated virus vaccination within 30 days prior to the first dose of study drug
  • Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
  • Any other autoimmune rheumatic disease, other than Sjogren's syndrome
  • Previous history of clinically significant infections or illness (requiring hospitalization or requiring parenteral therapy) within 90 days of the Screening visit, or a history of any illness that would preclude participation in the study
  • History of any malignancy, except for successfully treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
  • Does not meet specified washout criteria for the following RA medications: etanercept, certolizumab, adalimumab, golimumab, infliximab and tocilizumab, rituximab, abatacept, anakinra, methotrexate, sulfasalazine, hydroxychloroquine, gold, penicillamine or leflunamide
  • Previous intolerance to Janus kinase (JAK) inhibitors
  • Receipt of intra-articular or parenteral corticosteroid within 28 days prior to the first dose of study drug
  • Receipt of plasma exchange therapy within 60 days prior to the start of study drug
  • Receipt of any investigational agent within 30 days or 5 half-lives, whichever is longer, prior to first dose of study drug
  • Receipt of medications that are CYP3A substrates with narrow therapeutic range within 14 days prior to first dose of study drug
  • History of heart failure, defined as New York Heart Association (NYHA) grade 3 or greater
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Inc
Astellas Pharma Inc
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP