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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:6/24/2016
Start Date:September 2012
End Date:March 2016

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A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

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.

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.

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
We found this trial at
21
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Austin, Texas 78705
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Birmingham, Alabama 35216
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Birmingham, AL
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Brussels,
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Brussels,
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Chesapeake, Virginia 23320
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Chesapeake, VA
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Clarksburg, West Virginia 26301
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Clarksburg, WV
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Colorado Springs, Colorado 80920
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Colorado Springs, CO
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345 Twin Site Lane
Duncansville, Pennsylvania 16635
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Elizabethtown, Kentucky 42701
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Elizabethtown, KY
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Hickory, North Carolina 28602
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Hickory, NC
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Jacksonville, Florida 32216
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Jacksonville, FL
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Knoxville, Tennessee 37909
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Knoxville, TN
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LaJolla, California 92093
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Morton Grove, Illinois 60053
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Morton Grove, IL
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Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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Orlando, Florida 32804
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Palm Desert, California 92260
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Palm Desert, CA
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Palo Alto, California 94304
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Santa Maria, California 93454
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Santa Maria, CA
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Vernon Hills, Illinois 60061
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Vernon Hills, IL
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Wheaton, Maryland 20902
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Wheaton, MD
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Wyomissing, Pennsylvania 19610
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