- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01711814
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
May 20, 2019 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
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
Interventional
Enrollment (Actual)
611
Phase
- 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
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Brussels, Belgium, 1070
- Site BE3387
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Brussels, Belgium, 1190
- Site BE3314
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Burgas, Bulgaria, 8000
- Site BG3613
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Plovdiv, Bulgaria, 4003
- Site BG3217
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Sofia, Bulgaria, 1612
- Site BG3303
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Barranquilla, Atlantico, Colombia
- Site CO3326
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Bogota, Colombia
- Site CO3297
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Bucamaranga, Colombia
- Site CO2826
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Bucaramanga, Colombia
- Site CO3450
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Cali, Colombia
- Site CO3451
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Praha 2, Czechia, 128 50
- Site CZ3388
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Praha-Nusle, Czechia, 140 00
- Site CZ3376
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Uherske Hradiste, Czechia, 68601
- Site CZ3225
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Zlin, Czechia, 760 01
- Site CZ3449
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Balatonfüred, Hungary, 8230
- Site HU3461
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Bekescsaba, Hungary, 5600
- Site HU3398
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Budapest, Hungary, 1027
- Site HU3302
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Budapest, Hungary, 1027
- Site HU3448
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Budapest, Hungary, 1027
- Site HU3462
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Debrecen, Hungary, H-4043
- Site HU3447
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Guadalajara, Mexico, 44650
- Site MX3238
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Guadalajara, Jalisco, Mexico, 44280
- Site MX3307
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Mexico, Mexico, 6700
- Site MX3310
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Morelia, Mexico, 58070
- Site MX3317
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Bialystok, Poland, 15-879
- Site PL3391
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Bydgoszcz, Poland, 85-168
- Site PL2893
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Krakow, Poland, 31-637
- Site PL3603
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Lublin, Poland, 20-582
- Site PL3601
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Warszawa, Poland, 02-118
- Site PL3600
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Warszawa, Poland, 02-653
- Site PL3599
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Polska
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Bialystok, Polska, Poland, 15-351
- Site PL3233
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Alabama
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Birmingham, Alabama, United States, 35216
- Site US3218
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California
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La Jolla, California, United States, 92093-0943
- Site US828
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Palm Desert, California, United States, 92260
- Site US3227
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Palo Alto, California, United States, 94304
- Site US219
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Santa Maria, California, United States, 93454
- Site US3332
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Colorado
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Colorado Springs, Colorado, United States, 80920
- Site US3331
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Florida
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Jacksonville, Florida, United States, 32216
- Site US1894
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Orlando, Florida, United States, 32804
- Site US3232
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Illinois
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Morton Grove, Illinois, United States, 60053
- Site US702
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Vernon Hills, Illinois, United States, 60061
- Site US3226
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Kentucky
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Elizabethtown, Kentucky, United States, 42701
- Site US3329
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Maryland
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Wheaton, Maryland, United States, 20902
- Site US291
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North Carolina
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Hickory, North Carolina, United States, 28602
- Site US3298
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- Site US3300
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Site US345
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Wyomissing, Pennsylvania, United States, 19610
- Site US3304
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Tennessee
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Knoxville, Tennessee, United States, 37909
- Site US3306
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Texas
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Austin, Texas, United States, 78705
- Site US3319
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Virginia
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Chesapeake, Virginia, United States, 23320
- Site US3327
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West Virginia
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Clarksburg, West Virginia, United States, 26301
- Site US3320
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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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: ASP015K
Experimental
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oral
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety assessed by recording of adverse events and clinical laboratory evaluations
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
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)
September 26, 2012
Primary Completion (ACTUAL)
March 25, 2016
Study Completion (ACTUAL)
March 25, 2016
Study Registration Dates
First Submitted
October 19, 2012
First Submitted That Met QC Criteria
October 19, 2012
First Posted (ESTIMATE)
October 22, 2012
Study Record Updates
Last Update Posted (ACTUAL)
May 22, 2019
Last Update Submitted That Met QC Criteria
May 20, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Peficitinib
Other Study ID 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 compounds 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.
Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
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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