A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT01565655
Recruitment Status :
First Posted : March 29, 2012
Last Update Posted : December 16, 2014
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects
Condition or disease
Drug: ASP015KDrug: Placebo
Subjects will take ASP015K or matching placebo orally with food for 12 weeks after randomization. Potential subjects who have previously used disease-modifying antirheumatic drugs (DMARDs) and/or biologic agents may be eligible to participate after completing a washout period. Subjects who complete the 12-week dosing period in this study may be eligible to participate in a long-term, open-label Extension Study.
Triple (Participant, Care Provider, Outcomes Assessor)
A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
≥ 6 tender/painful joints; ≥ 6 swollen joints
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 Global Functional Status in RA Class I, II or III at Screening and Baseline
Use of non-steroidal anti-inflammatory drugs [NSAIDs], cyclooxygenase-2 (COX-2) inhibitors, or oral corticosteroids for the treatment of RA must be stable for at least 28 days prior to start of the study
Male and female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation
Female subject must not be breastfeeding at Screening or during the study period, and for 60 days after the final study drug administration
Subject agrees not to participate in another interventional study while on treatment
Positive Mycobacterium tuberculosis (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
Known history of positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody or history of a positive test for human immunodeficiency virus (HIV) infection
History of 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 Baseline 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: gold, azathioprine, minocycline, penicillamine, etanercept, certolizumab, adalimumab, golimumab, infliximab, cyclophosphamide, and 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 or is currently taking > 30 mg oral morphine (or narcotic equivalent) per day
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
History of long QT syndrome or prolonged QT interval
Any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or infectious disease, or any ongoing illness which would make the subject unsuitable for the study
Subject has any condition possibly affecting oral absorption (e.g., gastrectomy, other malabsorption syndromes, or clinically significant diabetic gastroenteropathy)