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
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 in Patients Who Have Had an Inadequate Response to Methotrexate
2 other identifiers
interventional
379
8 countries
49
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2012
49 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 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedStudy Start
First participant enrolled
July 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2014
CompletedMay 29, 2025
May 1, 2025
1.6 years
March 13, 2012
May 27, 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
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 daily in addition to concomitant weekly oral methotrexate
ASP015K low dose
EXPERIMENTALASP015K low dose daily in addition to concomitant weekly oral methotrexate
ASP015K medium dose
EXPERIMENTALASP015K medium dose daily in addition to concomitant weekly oral methotrexate
ASP015K high dose
EXPERIMENTALASP015K high dose daily in addition to concomitant weekly oral methotrexate
Placebo
PLACEBO COMPARATORPlacebo daily in addition to concomitant weekly oral methotrexate
Interventions
oral
Eligibility Criteria
You may qualify if:
- Subject has rheumatoid arthritis (RA) diagnosed according to the 1987 revised ACR criteria for at least 6 months prior to Screening
- 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
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
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
The Talbert Group
Huntington Beach, California, 92646, United States
University of California San Diego
La Jolla, California, 92093-0943, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454, United States
Arthritis Associates of Colorado Springs
Colorado Springs, Colorado, 80910, United States
Arthritis Associates
Orlando, Florida, 32804, United States
Illinois Bone & Joint
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
Center for Arthritis & Rheumatic Disease, P.C.
Chesapeake, Virginia, 23320, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
Hospital Erasme
Brussels, 1070, Belgium
Moliere Hospital
Brussels, 1190, Belgium
MHAT Burgas
Burgas, 8000, Bulgaria
MHAT Plovdiv AD
Plovdiv, 4003, Bulgaria
MHAT "Sv. Ivan Rilski"
Sofia, 1612, Bulgaria
IPS Rodrigo Botero SAS
Medellín, Antioquia, 5001000, 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, 128 50, 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
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, H-8230, Hungary
Rethy Pal Korhaz es Rendelointezet
Békéscsaba, 5600, Hungary
Revita Clinic Rheumatology
Budapest, 1027, Hungary
Kenezy Hospital Institute of Clinical Pharmacology
Debrecen, H-4043, Hungary
Morales Vargas Centro de Investigacion, SC Rheumatology
León, Guanajuato, 37000, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde Gutierrez
Guadalajara, 44280, Mexico
Dr Javier Orozco Alcala Private Doctor´s office
Guadalajara, 44650, Mexico
Cliditer S.A. de C.V.Huerta S.I.
Mexico City, 6700, Mexico
Centro de Investigacion Clinica de Morelia, S.C.
Morelia, 58070, Mexico
NZOZ Osteo-Medic sc A. Racewicz, J. Supronik
Bialystok, 15-351, Poland
Centrum Osteoporozy i Chorob KKostno-Stawowych Daniluk Clinical Research Centre
Bialystok, 15-461, Poland
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
Rheuma Medicus Zaktad Opieki Zdrowotnej Relle Brkolozka
Wraszawa, 02-118, Poland
Related Publications (1)
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.
PMID: 27748083DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2012
First Posted
March 15, 2012
Study Start
July 6, 2012
Primary Completion
February 11, 2014
Study Completion
February 11, 2014
Last Updated
May 29, 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/.