A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis
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 Patients
2 other identifiers
interventional
289
6 countries
38
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2012
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedStudy Start
First participant enrolled
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2013
CompletedMay 21, 2025
May 1, 2025
1.5 years
March 27, 2012
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response
Week 12
Trough plasma concentration of ASP015K and metabolite(s)
up to Week 12 (6 time points)
Secondary Outcomes (3)
Percentage of subjects achieving ACR 50 response
Week 12
Percentage of subjects achieving ACR 70 response
Week 12
Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP)
Baseline and Week 12
Study Arms (5)
ASP015K lowest dose
EXPERIMENTALASP015K lowest dose once daily
ASP015K low dose
EXPERIMENTALASP015K low dose once daily
ASP015K medium dose
EXPERIMENTALASP015K medium dose once daily
ASP015K high dose
EXPERIMENTALASP015K high dose once daily
Placebo
PLACEBO COMPARATORMatching placebo once daily
Interventions
oral
Eligibility Criteria
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
University of California San Diego
La Jolla, California, 92093-0943, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454, United States
Arthritis Associates of Colorado Springs
Colorado Springs, Colorado, 80910, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Arthritis Associates
Orlando, Florida, 32804, United States
Illinois Bone & Joint Institute; LLC
Morton Grove, Illinois, 60053, United States
Deerbrook Medical Asssociates
Vernon Hills, Illinois, 60061, United States
Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky, 42701, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
PMG Research
Hickory, North Carolina, 28602, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clincal Research Center of Reading
Wyomissing, Pennsylvania, 19610, United States
Rheumatology Consultants, PLLC
Knoxville, Tennessee, 37909-1907, United States
Austin Rheumatology Research PA
Austin, Texas, 78705, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
MHAT Burgas
Burgas, 8000, Bulgaria
MHAT Plovdiv AD
Plovdiv, 4003, Bulgaria
MHAT "Sv. Ivan Rilski"
Sofia, 1612, Bulgaria
Revmatologicky ustav
Prague, 128 50, Czechia
Revmatologicka ambulance
Praha-Nusle, 140 00, Czechia
MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.
Uherské Hradiště, 68601, Czechia
PV-MEDICAL s.r.o.
Zlín, 760 01, Czechia
Rethy Pal Korhaz es Rendelointezet
Békéscsaba, 5600, Hungary
Budai Irgalmasrendi Korhaz
Budapest, 1027, Hungary
Orszgos Reumatolgiai s Fizioterpis Intzet
Budapest, 1027, Hungary
Revita Clinic Rheumatology
Budapest, 1027, Hungary
Kenezy Hospital Institute of Clinical Pharmacology
Debrecen, H-4043, Hungary
Cliditer S.A. de C.V.
Mexico City, Mexico City, 6700, Mexico
Dr Javier Orozco Alcala Private Doctor´s office
Guadalajara, 44650, Mexico
Centro de Investigacion Clinica de Morelia, S.C.
Morelia, 58070, Mexico
Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela
Bydgoszcz, 85-168, Poland
NZOZ Centrum Medyczne ProMiMed
Krakow, 31-637, Poland
Zespol Poradni Specjalistycznych, REUMED sp. Zo.o
Lublin, 20-582, Poland
ARS Rheumatica
Warsaw, 02-653, Poland
Related Publications (2)
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.
PMID: 33068028DERIVEDGenovese 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.
PMID: 28118538DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
June 19, 2012
Primary Completion
December 2, 2013
Study Completion
December 2, 2013
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.