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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01711814

Enrollment

611

Registered

2012-10-22

Start date

2012-09-26

Completion date

2016-03-25

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis, ASP015K

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.

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.

Interventions

DRUGpeficitinib

oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety assessed by recording of adverse events and clinical laboratory evaluations	2 years

Countries

Belgium, Bulgaria, Colombia, Czechia, Hungary, Mexico, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026