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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
peficitinib
Sponsored by
Astellas Pharma Global Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, ASP015K

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site US3218
  • Site US828
  • Site US3227
  • Site US219
  • Site US3332
  • Site US3331
  • Site US1894
  • Site US3232
  • Site US702
  • Site US3226
  • Site US3329
  • Site US291
  • Site US3298
  • Site US3300
  • Site US345
  • Site US3304
  • Site US3306
  • Site US3319
  • Site US3327
  • Site US3320
  • Site BE3387
  • Site BE3314
  • Site BG3613
  • Site BG3217
  • Site BG3303
  • Site CO3326
  • Site CO3297
  • Site CO2826
  • Site CO3450
  • Site CO3451
  • Site CZ3388
  • Site CZ3376
  • Site CZ3225
  • Site CZ3449
  • Site HU3461
  • Site HU3398
  • Site HU3302
  • Site HU3448
  • Site HU3462
  • Site HU3447
  • Site MX3307
  • Site MX3238
  • Site MX3310
  • Site MX3317
  • Site PL3233
  • Site PL3391
  • Site PL2893
  • Site PL3603
  • Site PL3601
  • Site PL3600
  • Site PL3599

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASP015K

Arm Description

Experimental

Outcomes

Primary Outcome Measures

Safety assessed by recording of adverse events and clinical laboratory evaluations

Secondary Outcome Measures

Full Information

First Posted
October 19, 2012
Last Updated
May 20, 2019
Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Janssen Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01711814
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 26, 2012 (Actual)
Primary Completion Date
March 25, 2016 (Actual)
Study Completion Date
March 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Janssen Biotech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, ASP015K

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
611 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP015K
Arm Type
Experimental
Arm Description
Experimental
Intervention Type
Drug
Intervention Name(s)
peficitinib
Other Intervention Name(s)
ASP015K
Intervention Description
oral
Primary Outcome Measure Information:
Title
Safety assessed by recording of adverse events and clinical laboratory evaluations
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Site US3218
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Site US828
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0943
Country
United States
Facility Name
Site US3227
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Site US219
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Site US3332
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Site US3331
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Site US1894
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site US3232
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Site US702
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Site US3226
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Site US3329
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
Site US291
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Site US3298
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Site US3300
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Site US345
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site US3304
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Site US3306
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Site US3319
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site US3327
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Site US3320
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Site BE3387
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Site BE3314
City
Brussels
ZIP/Postal Code
1190
Country
Belgium
Facility Name
Site BG3613
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Site BG3217
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Site BG3303
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Site CO3326
City
Barranquilla, Atlantico
Country
Colombia
Facility Name
Site CO3297
City
Bogota
Country
Colombia
Facility Name
Site CO2826
City
Bucamaranga
Country
Colombia
Facility Name
Site CO3450
City
Bucaramanga
Country
Colombia
Facility Name
Site CO3451
City
Cali
Country
Colombia
Facility Name
Site CZ3388
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Site CZ3376
City
Praha-Nusle
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Site CZ3225
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Facility Name
Site CZ3449
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Site HU3461
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Site HU3398
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Site HU3302
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Site HU3448
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Site HU3462
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Site HU3447
City
Debrecen
ZIP/Postal Code
H-4043
Country
Hungary
Facility Name
Site MX3307
City
Guadalajara, Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Site MX3238
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Site MX3310
City
Mexico
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Site MX3317
City
Morelia
ZIP/Postal Code
58070
Country
Mexico
Facility Name
Site PL3233
City
Bialystok
State/Province
Polska
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Site PL3391
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Site PL2893
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Site PL3603
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Site PL3601
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Site PL3600
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Site PL3599
City
Warszawa
ZIP/Postal Code
02-653
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
31410787
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=324
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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