Clincosm LogoSign in Get a demo

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

Sponsor
Astellas Pharma Global Development, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01711814
Collaborator
Janssen Biotech, Inc. (Industry)
611
Enrollment
51
Locations
1
Arm
41.9
Actual Duration (Months)
12
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
611 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 26, 2012
Actual Primary Completion Date :
Mar 25, 2016
Actual Study Completion Date :
Mar 25, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASP015K

Experimental

Drug: peficitinib
oral
Other Names:
  • ASP015K

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety assessed by recording of adverse events and clinical laboratory evaluations [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site US3218 Birmingham Alabama United States 35216
    2 Site US828 La Jolla California United States 92093-0943
    3 Site US3227 Palm Desert California United States 92260
    4 Site US219 Palo Alto California United States 94304
    5 Site US3332 Santa Maria California United States 93454
    6 Site US3331 Colorado Springs Colorado United States 80920
    7 Site US1894 Jacksonville Florida United States 32216
    8 Site US3232 Orlando Florida United States 32804
    9 Site US702 Morton Grove Illinois United States 60053
    10 Site US3226 Vernon Hills Illinois United States 60061
    11 Site US3329 Elizabethtown Kentucky United States 42701
    12 Site US291 Wheaton Maryland United States 20902
    13 Site US3298 Hickory North Carolina United States 28602
    14 Site US3300 Oklahoma City Oklahoma United States 73103
    15 Site US345 Duncansville Pennsylvania United States 16635
    16 Site US3304 Wyomissing Pennsylvania United States 19610
    17 Site US3306 Knoxville Tennessee United States 37909
    18 Site US3319 Austin Texas United States 78705
    19 Site US3327 Chesapeake Virginia United States 23320
    20 Site US3320 Clarksburg West Virginia United States 26301
    21 Site BE3387 Brussels Belgium 1070
    22 Site BE3314 Brussels Belgium 1190
    23 Site BG3613 Burgas Bulgaria 8000
    24 Site BG3217 Plovdiv Bulgaria 4003
    25 Site BG3303 Sofia Bulgaria 1612
    26 Site CO3326 Barranquilla, Atlantico Colombia
    27 Site CO3297 Bogota Colombia
    28 Site CO2826 Bucamaranga Colombia
    29 Site CO3450 Bucaramanga Colombia
    30 Site CO3451 Cali Colombia
    31 Site CZ3388 Praha 2 Czechia 128 50
    32 Site CZ3376 Praha-Nusle Czechia 140 00
    33 Site CZ3225 Uherske Hradiste Czechia 68601
    34 Site CZ3449 Zlin Czechia 760 01
    35 Site HU3461 Balatonfüred Hungary 8230
    36 Site HU3398 Bekescsaba Hungary 5600
    37 Site HU3302 Budapest Hungary 1027
    38 Site HU3448 Budapest Hungary 1027
    39 Site HU3462 Budapest Hungary 1027
    40 Site HU3447 Debrecen Hungary H-4043
    41 Site MX3307 Guadalajara, Jalisco Mexico 44280
    42 Site MX3238 Guadalajara Mexico 44650
    43 Site MX3310 Mexico Mexico 6700
    44 Site MX3317 Morelia Mexico 58070
    45 Site PL3233 Bialystok Polska Poland 15-351
    46 Site PL3391 Bialystok Poland 15-879
    47 Site PL2893 Bydgoszcz Poland 85-168
    48 Site PL3603 Krakow Poland 31-637
    49 Site PL3601 Lublin Poland 20-582
    50 Site PL3600 Warszawa Poland 02-118
    51 Site PL3599 Warszawa Poland 02-653

    Sponsors and Collaborators

    • Astellas Pharma Global Development, Inc.
    • Janssen Biotech, Inc.

    Investigators

    • Study Director: Senior Medical Director, Astellas Pharma Global Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Global Development, Inc.
    ClinicalTrials.gov Identifier:
    NCT01711814
    Other Study ID Numbers:
    • 015K-CL-RA25
    • 2011-006021-23
    First Posted:
    Oct 22, 2012
    Last Update Posted:
    May 22, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Astellas Pharma Global Development, Inc.
    Rheumatoid Arthritis
    ASP015K
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Peficitinib

    Study Results

    No Results Posted as of May 22, 2019