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Arthritis, RheumatoidPhase 2NCT01649999

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

A Phase 2 study testing peficitinib in people with Arthritis, Rheumatoid, run by Astellas Pharma Inc at 7 sites in Japan.

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

This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects given ASP015K for 12 weeks. Read more about this study

Who is it for?
Ages 20 to 75 years
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
281 participants
Where
7 sitesJapan
Study dates
1 Mar 2012to 20 Jul 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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has received a full explanation of the study drug and this study in advance, and written informed consent to participate in the study has been obtained from the subject himself/herself
  • Outpatient has RA that was diagnosed according to the 1987 revised criteria of the ACR at least 6 months prior to screening
  • At screening subject has active RA as evidenced by all of the following:
  • ≥ 6 tender/painful joints;
  • ≥ 6 swollen joints;
  • CRP of ≥ 0.5 mg/dL or ESR of ≥ 28 mm/h.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 the Classification of Global Functional Status in RA, Class I, II or, III at screening

Who cannot join

  • Positive tuberculin (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
  • Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection
  • 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 Screening visit, or a history of any illness that would preclude participation in the study
Show all 14Show 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: etanercept, certolizumab, adalimumab, golimumab, infliximab and tocilizumab, rituximab, abatacept, anakinra, methotrexate, sulfasalazine, hydroxychloroquine, gold, penicillamine or 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
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Japan7 sites

  • Study site

    Chūbu

  • Study site

    Chugoku

  • Study site

    Hokkaido

  • Study site

    Kansai

  • Study site

    Kantou

  • Study site

    Kyushu

  • Study site

    Tōhoku

Other trials in Japan

About this study

Official title: Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients

This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects given ASP015K for 12 weeks.

Read the detailed description

This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, dose-finding, monotherapy, multi-center study with once daily oral ASP015K or matching placebo in subjects with moderate to severe RA, with or without prior antirheumatic medication, and regardless of responsiveness to the medication.

The study is comprised of up to a 4-week Screening period, a 12-week Treatment period and a 4-week Follow-up period.

Subjects in each treatment group will take ASP015K or matching placebo orally, once daily, after breakfast for 12 weeks after the screening period.

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 NCT01649999
Study groupRoleWhat they receive
ASP015K lowest doseExperimentalOral
Receives: Drug: peficitinib
ASP015K low doseExperimentalOral
Receives: Drug: peficitinib
ASP015K medium doseExperimentalOral
Receives: Drug: peficitinib
ASP015K high doseExperimentalOral
Receives: Drug: peficitinib
PlaceboPlacebo comparatorOral
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

Secondary outcomes (4)

  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

  4. Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and clinical labo-tests

    Measured: During 12-week treatment period and 4-week follow-up period

Timeline

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

  1. First posted25 Jul 2012 (estimated)
  2. Study start1 Mar 2012
  3. Primary completion20 Jul 2013
  4. Study completion20 Jul 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01649999
Sponsor's protocol ID
015K-CL-RAJ1
Status last verified
Oct 2024
First submitted
23 Jul 2012
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Toyoshima J, Kaibara A, Shibata M, Kaneko Y, Izutsu H, Nishimura T. Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacol Res Perspect. 2021 May;9(3):e00744. doi: 10.1002/prp2.744.

    PubMed 33929089

  • Takeuchi T, Tanaka Y, Iwasaki M, Ishikura H, Saeki S, Kaneko Y. Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study. Ann Rheum Dis. 2016 Jun;75(6):1057-64. doi: 10.1136/annrheumdis-2015-208279. Epub 2015 Dec 15.

    PubMed 26672064

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 Inc at 7 sites in Japan.

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 14 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan. 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). 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 NCT01649999, 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 Oct 2024.

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