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• Conditions: Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone; MedDRA version: 17.0Level: LLTClassification code 10042952Term: Systemic rheumatoid arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-006021-23-HU
• Lead Sponsor: Astellas Pharma Global Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-24
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Subject is eligible for the study if all of the following apply:
1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the Subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Male or female subject is at least 18 years of age at the time of Informed Consent.
3. Subject completed the week 12 visit in one of the Phase 2, ASP015K RA studies within the previous 14 days.
4. Female subject must be either:
? Of non child bearing potential:
o Post-menopausal (defined as at least 1 year without any menses) prior to
enrollment, or
o Documented surgically sterile or status post hysterectomy (at least 1 month
prior to enrollment)
? Or, if of childbearing potential,
o Must have a negative urine pregnancy test at enrollment, and
o Must use two forms of birth control1 (at least one of which must be a barrier
method) starting at enrollment and throughout the study period and for 60
days] after the final study drug administration.
5. Female subject must not be breastfeeding at Baseline/Day 1 or during the study period, and for 60 days after final study drug administration.
6. Female subject must not donate ova starting at Baseline/Day 1 and throughout the study period, and for 60 days after final study drug administration.
7. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Baseline/Day 1 and continue throughout the study period and for 90 days after the final study drug administration.
8. Male subject must not donate sperm starting at Baseline/Day 1 and throughout the study period, and for at least 90 days after final study drug administration.
9. Subject must be willing and able to comply with the study requirements.
10. Subject agrees not to participate in another interventional study while on treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 390

Exclusion Criteria

Subject will be excluded from participation if any of the following apply:
1. Subject has any condition considered by the Principal Investigator or Medical Monitor to preclude adequate evaluation of drug safety.
2. Subject is scheduled to receive any investigational drug other than ASP015K during the course of the study.
3. Subject is scheduled to receive a prohibited medication.
4. Subject has a planned major surgery.
5. 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.
6. Subject has any of the following laboratory values within the preceding 14 days prior to Day 1 study dosing, confirmed on re-test:
? Hemoglobin < 8 g/dL
? White blood cell count < 2000/mm3
? Absolute neutrophil count (ANC) < 1000/mm3
? Absolute lymphocyte count (ALC) < 500/mm3
? Platelet count < 50,000/mm3
? ALT = 3 x upper limit of normal
? AST = 3 x upper limit of normal
? Total bilirubin = 2 x upper limit of normal
? CPK > 1.5x 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective 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 ASP015K RA study;Secondary Objective: Not applicable;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable