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

May 27, 2025 updated by: Astellas Pharma Inc

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects in each treatment group will continue to take their concomitant oral weekly dose of methotrexate (MTX) in addition to daily ASP015K or matching placebo, taken orally with food, daily for 12 weeks after randomization.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
379

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hospital Erasme
      • Brussels, Belgium, 1190
        • Moliere Hospital
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • MHAT Burgas
      • Plovdiv, Bulgaria, 4003
        • MHAT Plovdiv AD
      • Sofia, Bulgaria, 1612
        • MHAT "Sv. Ivan Rilski"
  • Colombia
      • Barranquilla, Colombia
        • Centro Integral de Reumatología del Caribe S.A.S
      • Bogota, Colombia
        • Centro Integral De Reumatologia E Inmunologia
      • Bucaramanga, Colombia
        • Servimed E.U.
      • Bucaramanga, Colombia
        • Medicity SAS
      • Cali, Colombia
        • Centro de medicina Interna Julian Coronel
    • Antioquia
      • Medellin, Antioquia, Colombia, 5001000
        • IPS Rodrigo Botero SAS
  • Czechia
      • Praha 2, Czechia, 128 50
        • Revmatologicky ustav
      • Uherske Hradiste, Czechia, 68601
        • MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.
      • Zlin, Czechia, 760 01
        • PV-MEDICAL s.r.o.
  • Hungary
      • Balatonfured, Hungary, H-8230
        • DRC Gyogyszervizsgalo Kozpont Kft
      • Bekescsaba, Hungary, 5600
        • Rethy Pal Korhaz es Rendelointezet
      • Budapest, Hungary, 1027
        • Revita Clinic Rheumatology
      • Debrecen, Hungary, H-4043
        • Kenezy Hospital Institute of Clinical Pharmacology
  • Mexico
      • Guadalajara, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde Gutierrez
      • Guadalajara, Mexico, 44650
        • Dr Javier Orozco Alcala Private Doctor´s office
      • Mexico D.F., Mexico, 6700
        • Cliditer S.A. de C.V.Huerta S.I.
      • Morelia, Mexico, 58070
        • Centro de Investigacion Clinica de Morelia, S.C.
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Morales Vargas Centro de Investigacion, SC Rheumatology
  • Poland
      • Bialystok, Poland, 15-351
        • NZOZ Osteo-Medic sc A. Racewicz, J. Supronik
      • Bialystok, Poland, 15-461
        • Centrum Osteoporozy i Chorob KKostno-Stawowych Daniluk Clinical Research Centre
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela
      • Krakow, Poland, 31-637
        • NZOZ Centrum Medyczne ProMiMed
      • Lublin, Poland, 20-582
        • Zespol Poradni Specjalistycznych REUMED sp. Zo.o
      • Warszawa, Poland, 02-653
        • ARS Rheumatica
      • Wraszawa, Poland, 02-118
        • Rheuma Medicus Zaktad Opieki Zdrowotnej Relle Brkolozka
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC
    • California
      • Huntington Beach, California, United States, 92646
        • The Talbert Group
      • La Jolla, California, United States, 92093-0943
        • University Of California San Diego
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Santa Maria, California, United States, 93454
        • Pacific Arthritis Center Medical Group
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Arthritis Associates of Colorado Springs
    • Florida
      • Orlando, Florida, United States, 32804
        • Arthritis Associates
    • Illinois
      • Morton Grove, Illinois, United States, 60053
        • Illinois Bone & Joint
      • Vernon Hills, Illinois, United States, 60061
        • Deerbrook Medical Asssociates
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Center for Arthritis and Osteoporosis
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • PMG Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Wyomissing, Pennsylvania, United States, 19610
        • Clincal Research Center of Reading
    • Tennessee
      • Knoxville, Tennessee, United States, 37909-1907
        • Rheumatology Consultants, PLLC
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Rheumatology Research PA
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Center for Arthritis & Rheumatic Disease, P.C.
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Mountain State Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASP015K lowest dose
ASP015K lowest dose daily in addition to concomitant weekly oral methotrexate
Drug: peficitinib
oral
Other Names:
  • ASP015K
Drug: methotrexate
oral
Experimental: ASP015K low dose
ASP015K low dose daily in addition to concomitant weekly oral methotrexate
Drug: peficitinib
oral
Other Names:
  • ASP015K
Drug: methotrexate
oral
Experimental: ASP015K medium dose
ASP015K medium dose daily in addition to concomitant weekly oral methotrexate
Drug: peficitinib
oral
Other Names:
  • ASP015K
Drug: methotrexate
oral
Experimental: ASP015K high dose
ASP015K high dose daily in addition to concomitant weekly oral methotrexate
Drug: peficitinib
oral
Other Names:
  • ASP015K
Drug: methotrexate
oral
Placebo Comparator: Placebo
Placebo daily in addition to concomitant weekly oral methotrexate
Drug: Placebo
oral
Drug: methotrexate
oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response
Time Frame: Week 12
Week 12
Trough plasma concentration of ASP015K and metabolite(s)
Time Frame: up to Week 12
up to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of subjects achieving ACR 50 response
Time Frame: Week 12
Week 12
Percentage of subjects achieving ACR 70 response
Time Frame: Week 12
Week 12
Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP)
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Senior Medical Director Director, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 015K-CL-RA21
  • 2011-006018-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis, Rheumatoid

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings