Arthritis, Rheumatoid Clinical Trial
Official title:
Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients
Verified date | July 2019 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 281 |
Est. completion date | July 20, 2013 |
Est. primary completion date | July 20, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
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 leflunomide - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response | Week 12 | ||
Secondary | Percentage of Subjects achieving ACR 50 response | Week 12 | ||
Secondary | Percentage of Subjects achieving ACR 70 response | Week 12 | ||
Secondary | Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) | Baseline and Week 12 | ||
Secondary | Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and clinical labo-tests | During 12-week treatment period and 4-week follow-up period |
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