Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Global Development, Inc.
With
Janssen Biotech, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
