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Arthritis, RheumatoidPhase 2NCT01565655

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis

A Phase 2 study testing peficitinib in people with Arthritis, Rheumatoid, run by Astellas Pharma Global Development, Inc. at 38 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
289 participants
Where
38 sitesin 6 countries
Study dates
19 Jun 2012to 2 Dec 2013
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

  • ≥ 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

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 17Show 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
  • 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
  • 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
  • Subject has any condition possibly affecting oral absorption (e.g., gastrectomy, other malabsorption syndromes, or clinically significant diabetic gastroenteropathy)

Trial locations and contacts

38 sites in 6 countries.

38 sites in 6 countries

United States19 sites

  • Austin Rheumatology Research PA

    Austin, Texas, 78705

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • 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

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Rheumatology Consultants, PLLC

    Knoxville, Tennessee, 37909-1907

  • University of California San Diego

    La Jolla, California, 92093-0943

  • Illinois Bone & Joint Institute; LLC

    Morton Grove, Illinois, 60053

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Arthritis Associates

    Orlando, Florida, 32804

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • 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

Hungary5 sites

  • Rethy Pal Korhaz es Rendelointezet

    Békéscsaba, 5600

  • Budai Irgalmasrendi Korhaz

    Budapest, 1027

  • Orszgos Reumatolgiai s Fizioterpis Intzet

    Budapest, 1027

  • Revita Clinic Rheumatology

    Budapest, 1027

  • Kenezy Hospital Institute of Clinical Pharmacology

    Debrecen, H-4043

Other trials in Hungary

Czechia4 sites

  • Revmatologicky ustav

    Prague, 128 50

  • Revmatologicka ambulance

    Praha-Nusle, 140 00

  • 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

Poland4 sites

  • 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

Other trials in Poland

Bulgaria3 sites

  • MHAT Burgas

    Burgas, 8000

  • MHAT Plovdiv AD

    Plovdiv, 4003

  • MHAT "Sv. Ivan Rilski"

    Sofia, 1612

Other trials in Bulgaria

Mexico3 sites

  • Dr Javier Orozco Alcala Private Doctor´s office

    Guadalajara, 44650

  • Cliditer S.A. de C.V.

    Mexico City, Mexico City, 6700

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

    Morelia, 58070

Other trials in Mexico

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 Patients

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects

Read the detailed description

Subjects will take ASP015K or matching placebo orally with food for 12 weeks after randomization. Potential subjects who have previously used disease-modifying antirheumatic drugs (DMARDs) and/or biologic agents may be eligible to participate after completing a washout period. Subjects who complete the 12-week dosing period in this study may be eligible to participate in a long-term, open-label Extension Study.

Being tested
peficitinib, Placebo
Keywords
Rheumatoid Arthritis, ASP015K
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

Study groups in NCT01565655
Study groupRoleWhat they receive
ASP015K lowest doseExperimentalASP015K lowest dose once daily
Receives: Drug: peficitinib
ASP015K low doseExperimentalASP015K low dose once daily
Receives: Drug: peficitinib
ASP015K medium doseExperimentalASP015K medium dose once daily
Receives: Drug: peficitinib
ASP015K high doseExperimentalASP015K high dose once daily
Receives: Drug: peficitinib
PlaceboPlacebo comparatorMatching placebo once daily
Receives: Drug: Placebo

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 (6 time points)

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 posted29 Mar 2012 (estimated)
  2. Study start19 Jun 2012
  3. Primary completion2 Dec 2013
  4. Study completion2 Dec 2013

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01565655
Sponsor's protocol ID
015K-CL-RA22
Other IDs
2011-006020-20
Status last verified
May 2025
First submitted
27 Mar 2012
Last updated
21 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

  • 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.

    PubMed 33068028

  • Genovese 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.

    PubMed 28118538

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing peficitinib in people with Arthritis, Rheumatoid, run by Astellas Pharma Global Development, Inc. at 38 sites in 6 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 7 inclusion and 17 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 21 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 38 sites in United States, Hungary, Czechia, Poland, Bulgaria and 1 more country. 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 NCT01565655, which also lists 2 linked publications.

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 21 May 2025.

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