A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate
NCT ID: NCT01554696
Last Updated: 2025-05-29
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
379 participants
INTERVENTIONAL
2012-07-06
2014-02-11
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
QUADRUPLE
Study Groups
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ASP015K lowest dose
ASP015K lowest dose daily in addition to concomitant weekly oral methotrexate
peficitinib
oral
methotrexate
oral
ASP015K low dose
ASP015K low dose daily in addition to concomitant weekly oral methotrexate
peficitinib
oral
methotrexate
oral
ASP015K medium dose
ASP015K medium dose daily in addition to concomitant weekly oral methotrexate
peficitinib
oral
methotrexate
oral
ASP015K high dose
ASP015K high dose daily in addition to concomitant weekly oral methotrexate
peficitinib
oral
methotrexate
oral
Placebo
Placebo daily in addition to concomitant weekly oral methotrexate
Placebo
oral
methotrexate
oral
Interventions
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peficitinib
oral
Placebo
oral
methotrexate
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has been treated with oral methotrexate (MTX) for a minimum of 90 days and at a stable dose for 28 days prior to the first dose of study drug
* ≥6 tender/painful joints; ≥6 swollen joints
* Subject meets the ACR 1991 Revised Criteria for Global Functional Status in RA Class I, II or III at Screening and Baseline
* Subject's other medication taken for 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
* Subject has previously used a non anti-TNF biologic disease-modifying antirheumatic drug (DMARD) (e.g., anakinra, abatacept, rituximab, tocilizumab)
* 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
* Absolute lymphocyte count (ALC) \< 750/mm3
* 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. This includes stomatitis, gastrointestinal ulcers, or any other condition that would preclude continued treatment with methotrexate
* 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 Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
The Talbert Group
Huntington Beach, California, United States
University of California San Diego
La Jolla, California, United States
Desert Medical Advances
Palm Desert, California, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, United States
Arthritis Associates of Colorado Springs
Colorado Springs, Colorado, United States
Arthritis Associates
Orlando, Florida, United States
Illinois Bone & Joint
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
Center for Arthritis & Rheumatic Disease, P.C.
Chesapeake, Virginia, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
Hospital Erasme
Brussels, , Belgium
Moliere Hospital
Brussels, , Belgium
MHAT Burgas
Burgas, , Bulgaria
MHAT Plovdiv AD
Plovdiv, , Bulgaria
MHAT "Sv. Ivan Rilski"
Sofia, , Bulgaria
IPS Rodrigo Botero SAS
Medellín, Antioquia, Colombia
Centro Integral de Reumatología del Caribe S.A.S
Barranquilla, , Colombia
Centro Integral De Reumatologia E Inmunologia
Bogotá, , Colombia
Medicity Sas
Bucaramanga, , Colombia
Servimed E.U.
Bucaramanga, , Colombia
Centro de medicina Interna Julian Coronel
Cali, , Colombia
Revmatologicky ustav
Prague, , Czechia
MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.
Uherské Hradiště, , Czechia
PV-MEDICAL s.r.o.
Zlín, , Czechia
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, , Hungary
Rethy Pal Korhaz es Rendelointezet
Békéscsaba, , Hungary
Revita Clinic Rheumatology
Budapest, , Hungary
Kenezy Hospital Institute of Clinical Pharmacology
Debrecen, , Hungary
Morales Vargas Centro de Investigacion, SC Rheumatology
León, Guanajuato, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde Gutierrez
Guadalajara, , Mexico
Dr Javier Orozco Alcala Private Doctor´s office
Guadalajara, , Mexico
Cliditer S.A. de C.V.Huerta S.I.
Mexico City, , Mexico
Centro de Investigacion Clinica de Morelia, S.C.
Morelia, , Mexico
NZOZ Osteo-Medic sc A. Racewicz, J. Supronik
Bialystok, , Poland
Centrum Osteoporozy i Chorob KKostno-Stawowych Daniluk Clinical Research Centre
Bialystok, , Poland
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
Rheuma Medicus Zaktad Opieki Zdrowotnej Relle Brkolozka
Wraszawa, , Poland
Countries
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References
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Kivitz AJ, Gutierrez-Urena SR, Poiley J, Genovese MC, Kristy R, Shay K, Wang X, Garg JP, Zubrzycka-Sienkiewicz A. Peficitinib, a JAK Inhibitor, in the Treatment of Moderate-to-Severe Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2017 Apr;69(4):709-719. doi: 10.1002/art.39955.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2011-006018-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
015K-CL-RA21
Identifier Type: -
Identifier Source: org_study_id
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