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 |
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.
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.
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
sites
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