A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

October 17, 2024 updated by: Astellas Pharma Global Development, Inc.

A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study.

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

This study is comprised of a 104 week treatment period beginning on Day 1 of study drug administration and a 30-day follow-up period or permanent termination of clinical development of the product, whichever is earlier.

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.
611

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
        • Site BE3387
      • Brussels, Belgium, 1190
        • Site BE3314
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Site BG3613
      • Plovdiv, Bulgaria, 4003
        • Site BG3217
      • Sofia, Bulgaria, 1612
        • Site BG3303
  • Colombia
      • Barranquilla, Atlantico, Colombia
        • Site CO3326
      • Bogota, Colombia
        • Site CO3297
      • Bucamaranga, Colombia
        • Site CO2826
      • Bucaramanga, Colombia
        • Site CO3450
      • Cali, Colombia
        • Site CO3451
  • Czechia
      • Praha 2, Czechia, 128 50
        • Site CZ3388
      • Praha-Nusle, Czechia, 140 00
        • Site CZ3376
      • Uherske Hradiste, Czechia, 68601
        • Site CZ3225
      • Zlin, Czechia, 760 01
        • Site CZ3449
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Site HU3461
      • Bekescsaba, Hungary, 5600
        • Site HU3398
      • Budapest, Hungary, 1027
        • Site HU3302
      • Budapest, Hungary, 1027
        • Site HU3448
      • Budapest, Hungary, 1027
        • Site HU3462
      • Debrecen, Hungary, H-4043
        • Site HU3447
  • Mexico
      • Guadalajara, Mexico, 44650
        • Site MX3238
      • Guadalajara, Jalisco, Mexico, 44280
        • Site MX3307
      • Mexico, Mexico, 6700
        • Site MX3310
      • Morelia, Mexico, 58070
        • Site MX3317
  • Poland
      • Bialystok, Poland, 15-879
        • Site PL3391
      • Bydgoszcz, Poland, 85-168
        • Site PL2893
      • Krakow, Poland, 31-637
        • Site PL3603
      • Lublin, Poland, 20-582
        • Site PL3601
      • Warszawa, Poland, 02-118
        • Site PL3600
      • Warszawa, Poland, 02-653
        • Site PL3599
    • Polska
      • Bialystok, Polska, Poland, 15-351
        • Site PL3233
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Site US3218
    • California
      • La Jolla, California, United States, 92093-0943
        • Site US828
      • Palm Desert, California, United States, 92260
        • Site US3227
      • Palo Alto, California, United States, 94304
        • Site US219
      • Santa Maria, California, United States, 93454
        • Site US3332
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Site US3331
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Site US1894
      • Orlando, Florida, United States, 32804
        • Site US3232
    • Illinois
      • Morton Grove, Illinois, United States, 60053
        • Site US702
      • Vernon Hills, Illinois, United States, 60061
        • Site US3226
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Site US3329
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Site US291
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Site US3298
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Site US3300
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site US345
      • Wyomissing, Pennsylvania, United States, 19610
        • Site US3304
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Site US3306
    • Texas
      • Austin, Texas, United States, 78705
        • Site US3319
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Site US3327
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Site US3320

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject completed the week 12 visit in one of the Phase 2, ASP015K Rheumatoid Arthritis studies within the previous 14 days.
  • Male and Female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation

Exclusion Criteria:

  • Subject has any condition considered by the Principal Investigator or Medical Monitor to preclude adequate evaluation of drug safety
  • Subject is scheduled to receive any investigational drug other than ASP015K during the course of the study
  • Subject is scheduled to receive a prohibited medication
  • Subject has a planned major surgery
  • Subject discontinued study drug due to meeting study drug discontinuation criteria prior to completion of the Week 12 visit in the preceding study or fulfills study drug discontinuation criteria at the final study visit of the preceding study
  • Subject has out of range laboratory values within 14 days of the Day 1 study dosing
  • Absolute lymphocyte count (ALC) < 500/mm3
  • Creatine Phosphokinase (CPK) > 1.5 x upper limit of normal unless the level has been stable for at least 2 consecutive blood draws (at least 7 days apart), and subject does not have symptoms of muscle aching, weakness, or severe unusual muscle cramps

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
Experimental
Drug: peficitinib
oral
Other Names:
  • ASP015K

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
Safety assessed by recording of adverse events and clinical laboratory evaluations
Time Frame: 2 years
2 years

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 Global Development, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Biotech, 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, 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.
September 26, 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.
March 25, 2016

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.
March 25, 2016

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).
October 19, 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.
October 19, 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.
October 22, 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.
October 21, 2024

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.
October 17, 2024

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.
October 1, 2024

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-RA25
  • 2011-006021-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/.

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.

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