A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
NCT ID: NCT01711814
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
611 participants
INTERVENTIONAL
2012-09-26
2016-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ASP015K
Experimental
peficitinib
oral
Interventions
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peficitinib
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and Female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Biotech, Inc.
INDUSTRY
Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Site US3218
Birmingham, Alabama, United States
Site US828
La Jolla, California, United States
Site US3227
Palm Desert, California, United States
Site US219
Palo Alto, California, United States
Site US3332
Santa Maria, California, United States
Site US3331
Colorado Springs, Colorado, United States
Site US1894
Jacksonville, Florida, United States
Site US3232
Orlando, Florida, United States
Site US702
Morton Grove, Illinois, United States
Site US3226
Vernon Hills, Illinois, United States
Site US3329
Elizabethtown, Kentucky, United States
Site US291
Wheaton, Maryland, United States
Site US3298
Hickory, North Carolina, United States
Site US3300
Oklahoma City, Oklahoma, United States
Site US345
Duncansville, Pennsylvania, United States
Site US3304
Wyomissing, Pennsylvania, United States
Site US3306
Knoxville, Tennessee, United States
Site US3319
Austin, Texas, United States
Site US3327
Chesapeake, Virginia, United States
Site US3320
Clarksburg, West Virginia, United States
Site BE3387
Brussels, , Belgium
Site BE3314
Brussels, , Belgium
Site BG3613
Burgas, , Bulgaria
Site BG3217
Plovdiv, , Bulgaria
Site BG3303
Sofia, , 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, , Czechia
Site CZ3376
Praha-Nusle, , Czechia
Site CZ3225
Uherské Hradiště, , Czechia
Site CZ3449
Zlín, , Czechia
Site HU3461
Balatonfüred, , Hungary
Site HU3398
Békéscsaba, , Hungary
Site HU3302
Budapest, , Hungary
Site HU3448
Budapest, , Hungary
Site HU3462
Budapest, , Hungary
Site HU3447
Debrecen, , Hungary
Site MX3238
Guadalajara, , Mexico
Site MX3307
Guadalajara, Jalisco, , Mexico
Site MX3310
México, , Mexico
Site MX3317
Morelia, , Mexico
Site PL3233
Bialystok, Polska, Poland
Site PL3391
Bialystok, , Poland
Site PL2893
Bydgoszcz, , Poland
Site PL3603
Krakow, , Poland
Site PL3601
Lublin, , Poland
Site PL3600
Warsaw, , Poland
Site PL3599
Warsaw, , Poland
Countries
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References
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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.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2011-006021-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
015K-CL-RA25
Identifier Type: -
Identifier Source: org_study_id
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