A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis

Sponsor

Astellas Pharma Global Development, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01565655

Collaborator

(none)

289

Enrollment

Locations

Arms

17.4

Actual Duration (Months)

7.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: peficitinib Drug: Placebo	Phase 2

Detailed Description

Subjects will take ASP015K or matching placebo orally with food for 12 weeks after randomization. Potential subjects who have previously used disease-modifying antirheumatic drugs (DMARDs) and/or biologic agents may be eligible to participate after completing a washout period. Subjects who complete the 12-week dosing period in this study may be eligible to participate in a long-term, open-label Extension Study.

Study Design

Study Type:

Interventional

Actual Enrollment :

289 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Patients

Actual Study Start Date :

Jun 19, 2012

Actual Primary Completion Date :

Dec 2, 2013

Actual Study Completion Date :

Dec 2, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP015K lowest dose ASP015K lowest dose once daily	Drug: peficitinib oral Other Names: ASP015K
Experimental: ASP015K low dose ASP015K low dose once daily	Drug: peficitinib oral Other Names: ASP015K
Experimental: ASP015K medium dose ASP015K medium dose once daily	Drug: peficitinib oral Other Names: ASP015K
Experimental: ASP015K high dose ASP015K high dose once daily	Drug: peficitinib oral Other Names: ASP015K
Placebo Comparator: Placebo Matching placebo once daily	Drug: Placebo oral

Outcome Measures

Primary Outcome Measures

Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response [Week 12]
Trough plasma concentration of ASP015K and metabolite(s) [up to Week 12 (6 time points)]

Secondary Outcome Measures

Percentage of subjects achieving ACR 50 response [Week 12]
Percentage of subjects achieving ACR 70 response [Week 12]
Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) [Baseline and Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 6 tender/painful joints; ≥ 6 swollen joints
C-Reactive Protein (CRP) of ≥ 0.8 mg/dL or Erythrocyte Sedimentation Rate (ESR) of ≥ 28 mm/hr
Subject meets the ACR 1991 Revised Criteria for Global Functional Status in RA Class I, II or III at Screening and Baseline
Use of non-steroidal anti-inflammatory drugs [NSAIDs], cyclooxygenase-2 (COX-2) inhibitors, or oral corticosteroids for the treatment of RA must be stable for at least 28 days prior to start of the study
Male and female subjects must be willing to comply with contraception requirements as well as restrictions regarding egg and sperm donation
Female subject must not be breastfeeding at Screening or during the study period, and for 60 days after the final study drug administration
Subject agrees not to participate in another interventional study while on treatment

Exclusion Criteria:

Positive Mycobacterium tuberculosis (TB) test within 90 days of Screening
Abnormal chest x-ray indicative of an acute or chronic infectious process or malignancy
Receipt of live or live attenuated virus vaccination within 30 days prior to the first dose of study drug
Known history of positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody or history of a positive test for human immunodeficiency virus (HIV) infection
History of any other autoimmune rheumatic disease, other than Sjogren's syndrome
Previous history of clinically significant infections or illness (requiring hospitalization or requiring parenteral therapy) within 90 days of the Baseline visit, or a history of any illness that would preclude participation in the study
History of any malignancy, except for successfully treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix.
Does not meet specified washout criteria for the following RA medications: gold, azathioprine, minocycline, penicillamine, etanercept, certolizumab, adalimumab, golimumab, infliximab, cyclophosphamide, and leflunomide
Previous intolerance to Janus kinase (JAK) inhibitors
Receipt of intra-articular or parenteral corticosteroid within 28 days prior to the first dose of study drug or is currently taking > 30 mg oral morphine (or narcotic equivalent) per day
Receipt of plasma exchange therapy within 60 days prior to the start of study drug
Receipt of any investigational agent within 30 days or 5 half-lives, whichever is longer, prior to first dose of study drug
Receipt of medications that are CYP3A substrates with narrow therapeutic range within 14 days prior to first dose of study drug
History of heart failure, defined as New York Heart Association (NYHA) grade 3 or greater
History of long QT syndrome or prolonged QT interval
Any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or infectious disease, or any ongoing illness which would make the subject unsuitable for the study
Subject has any condition possibly affecting oral absorption (e.g., gastrectomy, other malabsorption syndromes, or clinically significant diabetic gastroenteropathy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Achieve Clinical Research, LLC	Birmingham	Alabama	United States	35216
2	University of California San Diego	La Jolla	California	United States	92093-0943
3	Desert Medical Advances	Palm Desert	California	United States	92260
4	Stanford University School of Medicine	Palo Alto	California	United States	94304
5	Pacific Arthritis Center Medical Group	Santa Maria	California	United States	93454
6	Arthritis Associates of Colorado Springs	Colorado Springs	Colorado	United States	80910
7	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
8	Arthritis Associates	Orlando	Florida	United States	32804
9	Illinois Bone & Joint Institute; LLC	Morton Grove	Illinois	United States	60053
10	Deerbrook Medical Asssociates	Vernon Hills	Illinois	United States	60061
11	Center for Arthritis and Osteoporosis	Elizabethtown	Kentucky	United States	42701
12	The Center for Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
13	PMG Research	Hickory	North Carolina	United States	28602
14	Health Research of Oklahoma	Oklahoma City	Oklahoma	United States	73103
15	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
16	Clincal Research Center of Reading	Wyomissing	Pennsylvania	United States	19610
17	Rheumatology Consultants, PLLC	Knoxville	Tennessee	United States	37909-1907
18	Austin Rheumatology Research PA	Austin	Texas	United States	78705
19	Mountain State Clinical Research	Clarksburg	West Virginia	United States	26301
20	MHAT Burgas	Burgas		Bulgaria	8000
21	MHAT Plovdiv AD	Plovdiv		Bulgaria	4003
22	MHAT "Sv. Ivan Rilski"	Sofia		Bulgaria	1612
23	Revmatologicky ustav	Praha 2		Czechia	128 50
24	Revmatologicka ambulance	Praha-Nusle		Czechia	140 00
25	MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.	Uherske Hradiste		Czechia	68601
26	PV-MEDICAL s.r.o.	Zlin		Czechia	760 01
27	Rethy Pal Korhaz es Rendelointezet	Bekescsaba		Hungary	5600
28	Budai Irgalmasrendi Korhaz	Budapest,		Hungary	1027
29	Orszgos Reumatolgiai s Fizioterpis Intzet	Budapest		Hungary	1027
30	Revita Clinic Rheumatology	Budapest		Hungary	1027
31	Kenezy Hospital Institute of Clinical Pharmacology	Debrecen		Hungary	H-4043
32	Cliditer S.A. de C.V.	México	Distrito Federal	Mexico	6700
33	Dr Javier Orozco Alcala Private Doctor´s office	Guadalajara		Mexico	44650
34	Centro de Investigacion Clinica de Morelia, S.C.	Morelia		Mexico	58070
35	Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela	Bydgoszcz		Poland	85-168
36	NZOZ Centrum Medyczne ProMiMed	Krakow		Poland	31-637
37	Zespol Poradni Specjalistycznych, REUMED sp. Zo.o	Lublin		Poland	20-582
38	ARS Rheumatica	Warszawa		Poland	02-653