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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 October 2024
• Main ID: NCT01711814
• Date of registration: 19/10/2012
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Global Development, Inc.
• Public title: A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
• Scientific title: 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
• Date of first enrolment: September 26, 2012
• Target sample size: 611
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01711814
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Senior Medical Director
• Affiliation: Astellas Pharma Global Development

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: peficitinib

Primary Outcome(s)

Safety assessed by recording of adverse events and clinical laboratory evaluations [Time Frame: 2 years]

Secondary ID(s)

2011-006021-23

015K-CL-RA25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen Biotech, Inc.