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Arthritis, RheumatoidPhase 2NCT01554696

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 2 study testing peficitinib and methotrexate in people with Arthritis, Rheumatoid, run by Astellas Pharma Inc at 49 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
peficitinib and methotrexate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
379 participants
Where
49 sitesin 8 countries
Study dates
6 Jul 2012to 11 Feb 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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)

Trial locations and contacts

49 sites in 8 countries.

49 sites in 8 countries

United States19 sites

  • Austin Rheumatology Research PA

    Austin, Texas, 78705

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Center for Arthritis & Rheumatic Disease, P.C.

    Chesapeake, Virginia, 23320

  • Mountain State Clinical Research

    Clarksburg, West Virginia, 26301

  • Arthritis Associates of Colorado Springs

    Colorado Springs, Colorado, 80910

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Center for Arthritis and Osteoporosis

    Elizabethtown, Kentucky, 42701

  • PMG Research

    Hickory, North Carolina, 28602

  • The Talbert Group

    Huntington Beach, California, 92646

  • Rheumatology Consultants, PLLC

    Knoxville, Tennessee, 37909-1907

  • University of California San Diego

    La Jolla, California, 92093-0943

  • Illinois Bone & Joint

    Morton Grove, Illinois, 60053

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Arthritis Associates

    Orlando, Florida, 32804

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Pacific Arthritis Center Medical Group

    Santa Maria, California, 93454

  • Deerbrook Medical Asssociates

    Vernon Hills, Illinois, 60061

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Clincal Research Center of Reading

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland7 sites

  • NZOZ Osteo-Medic sc A. Racewicz, J. Supronik

    Bialystok, 15-351

  • Centrum Osteoporozy i Chorob KKostno-Stawowych Daniluk Clinical Research Centre

    Bialystok, 15-461

  • Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela

    Bydgoszcz, 85-168

  • NZOZ Centrum Medyczne ProMiMed

    Krakow, 31-637

  • Zespol Poradni Specjalistycznych REUMED sp. Zo.o

    Lublin, 20-582

  • ARS Rheumatica

    Warsaw, 02-653

  • Rheuma Medicus Zaktad Opieki Zdrowotnej Relle Brkolozka

    Wraszawa, 02-118

Other trials in Poland

Colombia6 sites

  • Centro Integral de Reumatología del Caribe S.A.S

    Barranquilla

  • Centro Integral De Reumatologia E Inmunologia

    Bogotá

  • Medicity Sas

    Bucaramanga

  • Servimed E.U.

    Bucaramanga

  • Centro de medicina Interna Julian Coronel

    Cali

  • IPS Rodrigo Botero SAS

    Medellín, Antioquia, 5001000

Other trials in Colombia

Mexico5 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde Gutierrez

    Guadalajara, 44280

  • Dr Javier Orozco Alcala Private Doctor´s office

    Guadalajara, 44650

  • Morales Vargas Centro de Investigacion, SC Rheumatology

    León, Guanajuato, 37000

  • Cliditer S.A. de C.V.Huerta S.I.

    Mexico City, 6700

  • Centro de Investigacion Clinica de Morelia, S.C.

    Morelia, 58070

Other trials in Mexico

Hungary4 sites

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, H-8230

  • Rethy Pal Korhaz es Rendelointezet

    Békéscsaba, 5600

  • Revita Clinic Rheumatology

    Budapest, 1027

  • Kenezy Hospital Institute of Clinical Pharmacology

    Debrecen, H-4043

Other trials in Hungary

Bulgaria3 sites

  • MHAT Burgas

    Burgas, 8000

  • MHAT Plovdiv AD

    Plovdiv, 4003

  • MHAT "Sv. Ivan Rilski"

    Sofia, 1612

Other trials in Bulgaria

Czechia3 sites

  • Revmatologicky ustav

    Prague, 128 50

  • MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.

    Uherské Hradiště, 68601

  • PV-MEDICAL s.r.o.

    Zlín, 760 01

Other trials in Czechia

Belgium2 sites

  • Hospital Erasme

    Brussels, 1070

  • Moliere Hospital

    Brussels, 1190

Other trials in Belgium

About this study

Official title: 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).

Read the 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.

Being tested
peficitinib, Placebo, methotrexate
Keywords
ASP015K, Rheumatoid Arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peficitinibDrug

    Also called ASP015K

    oral

  • PlaceboDrug

    oral

  • methotrexateDrug

    oral

Study groups in NCT01554696
Study groupRoleWhat they receive
ASP015K lowest doseExperimentalASP015K lowest dose daily in addition to concomitant weekly oral methotrexate
Receives: Drug: peficitinib; Drug: methotrexate
ASP015K low doseExperimentalASP015K low dose daily in addition to concomitant weekly oral methotrexate
Receives: Drug: peficitinib; Drug: methotrexate
ASP015K medium doseExperimentalASP015K medium dose daily in addition to concomitant weekly oral methotrexate
Receives: Drug: peficitinib; Drug: methotrexate
ASP015K high doseExperimentalASP015K high dose daily in addition to concomitant weekly oral methotrexate
Receives: Drug: peficitinib; Drug: methotrexate
PlaceboPlacebo comparatorPlacebo daily in addition to concomitant weekly oral methotrexate
Receives: Drug: Placebo; Drug: methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response

    Measured: Week 12

  2. Trough plasma concentration of ASP015K and metabolite(s)

    Measured: up to Week 12

Secondary outcomes (3)

  1. Percentage of subjects achieving ACR 50 response

    Measured: Week 12

  2. Percentage of subjects achieving ACR 70 response

    Measured: Week 12

  3. Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP)

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2012 (estimated)
  2. Study start6 Jul 2012
  3. Primary completion11 Feb 2014
  4. Study completion11 Feb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01554696
Sponsor's protocol ID
015K-CL-RA21
Other IDs
2011-006018-15
Status last verified
May 2025
First submitted
13 Mar 2012
Last updated
29 May 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: 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/.

Publications

  • 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.

    PubMed 27748083

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing peficitinib and methotrexate in people with Arthritis, Rheumatoid, run by Astellas Pharma Inc at 49 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Poland, Colombia, Mexico, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01554696, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.

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