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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
ASP015K
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Janssen Biotech, Inc.
First posted: 2012-10-22
Enrollment: 611
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety assessed by recording of adverse events and clinical laboratory evaluations
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site US3218
state: Alabama
city: La Jolla
country: United States
facility: Site US828
state: California
city: Palm Desert
country: United States
facility: Site US3227
state: California
city: Palo Alto
country: United States
facility: Site US219
state: California
city: Santa Maria
country: United States
facility: Site US3332
state: California
city: Colorado Springs
country: United States
facility: Site US3331
state: Colorado
city: Jacksonville
country: United States
facility: Site US1894
state: Florida
city: Orlando
country: United States
facility: Site US3232
state: Florida
city: Morton Grove
country: United States
facility: Site US702
state: Illinois
city: Vernon Hills
country: United States
facility: Site US3226
state: Illinois
city: Elizabethtown
country: United States
facility: Site US3329
state: Kentucky
city: Wheaton
country: United States
facility: Site US291
state: Maryland
city: Hickory
country: United States
facility: Site US3298
state: North Carolina
city: Oklahoma City
country: United States
facility: Site US3300
state: Oklahoma
city: Duncansville
country: United States
facility: Site US345
state: Pennsylvania
city: Wyomissing
country: United States
facility: Site US3304
state: Pennsylvania
city: Knoxville
country: United States
facility: Site US3306
state: Tennessee
city: Austin
country: United States
facility: Site US3319
state: Texas
city: Chesapeake
country: United States
facility: Site US3327
state: Virginia
city: Clarksburg
country: United States
facility: Site US3320
state: West Virginia
city: Brussels
country: Belgium
facility: Site BE3387
city: Brussels
country: Belgium
facility: Site BE3314
city: Burgas
country: Bulgaria
facility: Site BG3613
city: Plovdiv
country: Bulgaria
facility: Site BG3217
city: Sofia
country: Bulgaria
facility: Site BG3303
city: Barranquilla, Atlantico
country: Colombia
facility: Site CO3326
city: Bogota
country: Colombia
facility: Site CO3297
city: Bucamaranga
country: Colombia
facility: Site CO2826
city: Bucaramanga
country: Colombia
facility: Site CO3450
city: Cali
country: Colombia
facility: Site CO3451
city: Praha 2
country: Czechia
facility: Site CZ3388
city: Praha-Nusle
country: Czechia
facility: Site CZ3376
city: Uherske Hradiste
country: Czechia
facility: Site CZ3225
city: Zlin
country: Czechia
facility: Site CZ3449
city: Balatonfüred
country: Hungary
facility: Site HU3461
city: Bekescsaba
country: Hungary
facility: Site HU3398
city: Budapest
country: Hungary
facility: Site HU3302
city: Budapest
country: Hungary
facility: Site HU3448
city: Budapest
country: Hungary
facility: Site HU3462
city: Debrecen
country: Hungary
facility: Site HU3447
city: Guadalajara, Jalisco
country: Mexico
facility: Site MX3307
city: Guadalajara
country: Mexico
facility: Site MX3238
city: Mexico
country: Mexico
facility: Site MX3310
city: Morelia
country: Mexico
facility: Site MX3317
city: Bialystok
country: Poland
facility: Site PL3233
state: Polska
city: Bialystok
country: Poland
facility: Site PL3391
city: Bydgoszcz
country: Poland
facility: Site PL2893
city: Krakow
country: Poland
facility: Site PL3603
city: Lublin
country: Poland
facility: Site PL3601
city: Warszawa
country: Poland
facility: Site PL3600
city: Warszawa
country: Poland
facility: Site PL3599
Study officials:
affiliation: Astellas Pharma Global Development
name: Senior Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.