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

Completed · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects

Key facts

Study ID

NCT01565655

Run by

Astellas Pharma Global Development, Inc.

People needed

289

Starts

2012-06-19

Expected to finish

2013-12-02

Last updated by the study team

2025-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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)

Where it is running

• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• University of California San Diego — La Jolla, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• Pacific Arthritis Center Medical Group — Santa Maria, California, United States
• Arthritis Associates of Colorado Springs — Colorado Springs, Colorado, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Arthritis Associates — Orlando, Florida, United States
• Illinois Bone & Joint Institute; LLC — Morton Grove, Illinois, United States
• Deerbrook Medical Asssociates — Vernon Hills, Illinois, United States
• Center for Arthritis and Osteoporosis — Elizabethtown, Kentucky, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• PMG Research — Hickory, North Carolina, United States
• Health Research of Oklahoma — Oklahoma City, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Clincal Research Center of Reading — Wyomissing, Pennsylvania, United States
• Rheumatology Consultants, PLLC — Knoxville, Tennessee, United States
• Austin Rheumatology Research PA — Austin, Texas, United States
• Mountain State Clinical Research — Clarksburg, West Virginia, United States
• MHAT Burgas — Burgas, Bulgaria
• MHAT Plovdiv AD — Plovdiv, Bulgaria
• MHAT "Sv. Ivan Rilski" — Sofia, Bulgaria
• Revmatologicky ustav — Prague, Czechia
• Revmatologicka ambulance — Praha-Nusle, Czechia
• MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o. — Uherské Hradiště, Czechia

Full record on ClinicalTrials.gov

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