A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
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
2 other identifiers
interventional
611
8 countries
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Typical duration for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2012
CompletedFirst Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2016
CompletedOctober 21, 2024
October 1, 2024
3.5 years
October 19, 2012
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety assessed by recording of adverse events and clinical laboratory evaluations
2 years
Study Arms (1)
ASP015K
EXPERIMENTALExperimental
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Janssen Biotech, Inc.collaborator
Study Sites (51)
Site US3218
Birmingham, Alabama, 35216, United States
Site US828
La Jolla, California, 92093-0943, United States
Site US3227
Palm Desert, California, 92260, United States
Site US219
Palo Alto, California, 94304, United States
Site US3332
Santa Maria, California, 93454, United States
Site US3331
Colorado Springs, Colorado, 80920, United States
Site US1894
Jacksonville, Florida, 32216, United States
Site US3232
Orlando, Florida, 32804, United States
Site US702
Morton Grove, Illinois, 60053, United States
Site US3226
Vernon Hills, Illinois, 60061, United States
Site US3329
Elizabethtown, Kentucky, 42701, United States
Site US291
Wheaton, Maryland, 20902, United States
Site US3298
Hickory, North Carolina, 28602, United States
Site US3300
Oklahoma City, Oklahoma, 73103, United States
Site US345
Duncansville, Pennsylvania, 16635, United States
Site US3304
Wyomissing, Pennsylvania, 19610, United States
Site US3306
Knoxville, Tennessee, 37909, United States
Site US3319
Austin, Texas, 78705, United States
Site US3327
Chesapeake, Virginia, 23320, United States
Site US3320
Clarksburg, West Virginia, 26301, United States
Site BE3387
Brussels, 1070, Belgium
Site BE3314
Brussels, 1190, Belgium
Site BG3613
Burgas, 8000, Bulgaria
Site BG3217
Plovdiv, 4003, Bulgaria
Site BG3303
Sofia, 1612, Bulgaria
Site CO3326
Barranquilla, Atlantico, Colombia
Site CO3297
Bogotá, Colombia
Site CO2826
Bucamaranga, Colombia
Site CO3450
Bucaramanga, Colombia
Site CO3451
Cali, Colombia
Site CZ3388
Prague, 128 50, Czechia
Site CZ3376
Praha-Nusle, 140 00, Czechia
Site CZ3225
Uherské Hradiště, 68601, Czechia
Site CZ3449
Zlín, 760 01, Czechia
Site HU3461
Balatonfüred, 8230, Hungary
Site HU3398
Békéscsaba, 5600, Hungary
Site HU3302
Budapest, 1027, Hungary
Site HU3448
Budapest, 1027, Hungary
Site HU3462
Budapest, 1027, Hungary
Site HU3447
Debrecen, H-4043, Hungary
Site MX3238
Guadalajara, 44650, Mexico
Site MX3307
Guadalajara, Jalisco, 44280, Mexico
Site MX3310
México, 6700, Mexico
Site MX3317
Morelia, 58070, Mexico
Site PL3233
Bialystok, Polska, 15-351, Poland
Site PL3391
Bialystok, 15-879, Poland
Site PL2893
Bydgoszcz, 85-168, Poland
Site PL3603
Krakow, 31-637, Poland
Site PL3601
Lublin, 20-582, Poland
Site PL3600
Warsaw, 02-118, Poland
Site PL3599
Warsaw, 02-653, Poland
Related Publications (1)
Genovese MC, Greenwald MW, Gutierrez-Urena SR, Cardiel MH, Poiley JE, Zubrzycka-Sienkiewicz A, Codding CE, Wang A, He W, Amos R, Vinueza R, Wang X, Garg JP, Kivitz AJ. Two-Year Safety and Effectiveness of Peficitinib in Moderate-To-Severe Rheumatoid Arthritis: A Phase IIb, Open-Label Extension Study. Rheumatol Ther. 2019 Dec;6(4):503-520. doi: 10.1007/s40744-019-00167-6. Epub 2019 Aug 13.
PMID: 31410787DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Senior Medical Director
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 22, 2012
Study Start
September 26, 2012
Primary Completion
March 25, 2016
Study Completion
March 25, 2016
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/.