A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT01565655
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
289 participants
INTERVENTIONAL
2012-06-19
2013-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ASP015K lowest dose
ASP015K lowest dose once daily
peficitinib
oral
ASP015K low dose
ASP015K low dose once daily
peficitinib
oral
ASP015K medium dose
ASP015K medium dose once daily
peficitinib
oral
ASP015K high dose
ASP015K high dose once daily
peficitinib
oral
Placebo
Matching placebo once daily
Placebo
oral
Interventions
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peficitinib
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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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
PV-MEDICAL s.r.o.
Zlín, , Czechia
Rethy Pal Korhaz es Rendelointezet
Békéscsaba, , Hungary
Budai Irgalmasrendi Korhaz
Budapest, , Hungary
Orszgos Reumatolgiai s Fizioterpis Intzet
Budapest, , Hungary
Revita Clinic Rheumatology
Budapest, , Hungary
Kenezy Hospital Institute of Clinical Pharmacology
Debrecen, , Hungary
Cliditer S.A. de C.V.
Mexico City, Mexico City, Mexico
Dr Javier Orozco Alcala Private Doctor´s office
Guadalajara, , Mexico
Centro de Investigacion Clinica de Morelia, S.C.
Morelia, , Mexico
Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela
Bydgoszcz, , Poland
NZOZ Centrum Medyczne ProMiMed
Krakow, , Poland
Zespol Poradni Specjalistycznych, REUMED sp. Zo.o
Lublin, , Poland
ARS Rheumatica
Warsaw, , Poland
Countries
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References
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Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
Genovese MC, Greenwald M, Codding C, Zubrzycka-Sienkiewicz A, Kivitz AJ, Wang A, Shay K, Wang X, Garg JP, Cardiel MH. Peficitinib, a JAK Inhibitor, in Combination With Limited Conventional Synthetic Disease-Modifying Antirheumatic Drugs in the Treatment of Moderate-to-Severe Rheumatoid Arthritis. Arthritis Rheumatol. 2017 May;69(5):932-942. doi: 10.1002/art.40054.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2011-006020-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
015K-CL-RA22
Identifier Type: -
Identifier Source: org_study_id
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