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

Astellas

Status and phase

Completed

Phase 2

Conditions

Arthritis, Rheumatoid

Treatments

Drug: peficitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01711814

015K-CL-RA25

2011-006021-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

611 patients

Sex

All

Ages

18+ years old

Volunteers

No 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