A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

Arthritis, Rheumatoid Clinical Trial

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 in Patients Who Have Had an Inadequate Response to Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554696
• Other study ID #: 015K-CL-RA21
• Secondary ID: 2011-006018-15
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2012
• Est. completion date: February 11, 2014

Study information

• Verified date: May 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).

Description:

Subjects in each treatment group will continue to take their concomitant oral weekly dose of methotrexate (MTX) in addition to daily ASP015K or matching placebo, taken orally with food, daily for 12 weeks after randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: February 11, 2014
• Est. primary completion date: February 11, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has rheumatoid arthritis (RA) diagnosed according to the 1987 revised ACR criteria for at least 6 months prior to Screening

• Subject has been treated with oral methotrexate (MTX) for a minimum of 90 days and at a stable dose for 28 days prior to the first dose of study drug

• =6 tender/painful joints; =6 swollen joints

• Subject meets the ACR 1991 Revised Criteria for Global Functional Status in RA Class I, II or III at Screening and Baseline

• Subject's other medication taken for 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

• Subject has previously used a non anti-TNF biologic disease-modifying antirheumatic drug (DMARD) (e.g., anakinra, abatacept, rituximab, tocilizumab)

• 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

• Absolute lymphocyte count (ALC) < 750/mm3

• 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. This includes stomatitis, gastrointestinal ulcers, or any other condition that would preclude continued treatment with methotrexate

• Subject has any condition possibly affecting oral absorption (e.g., gastrectomy, other malabsorption syndromes, or clinically significant diabetic gastroenteropathy)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• peficitinib
oral
• Placebo
oral
• methotrexate
oral

Locations

Country	Name	City	State
Belgium	Hospital Erasme	Brussels
Belgium	Moliere Hospital	Brussels
Bulgaria	MHAT Burgas	Burgas
Bulgaria	MHAT Plovdiv AD	Plovdiv
Bulgaria	MHAT "Sv. Ivan Rilski"	Sofia
Colombia	Centro Integral de Reumatología del Caribe S.A.S	Barranquilla
Colombia	Centro Integral De Reumatologia E Inmunologia	Bogota
Colombia	Medicity Sas	Bucaramanga
Colombia	Servimed E.U.	Bucaramanga
Colombia	Centro de medicina Interna Julian Coronel	Cali
Colombia	IPS Rodrigo Botero SAS	Medellin	Antioquia
Czechia	Revmatologicky ustav	Praha 2
Czechia	MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.	Uherske Hradiste
Czechia	PV-MEDICAL s.r.o.	Zlin
Hungary	DRC Gyogyszervizsgalo Kozpont Kft	Balatonfured
Hungary	Rethy Pal Korhaz es Rendelointezet	Bekescsaba
Hungary	Revita Clinic Rheumatology	Budapest
Hungary	Kenezy Hospital Institute of Clinical Pharmacology	Debrecen
Mexico	Dr Javier Orozco Alcala Private Doctor´s office	Guadalajara
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde Gutierrez	Guadalajara
Mexico	Morales Vargas Centro de Investigacion, SC Rheumatology	Leon	Guanajuato
Mexico	Cliditer S.A. de C.V.Huerta S.I.	Mexico D.F.
Mexico	Centro de Investigacion Clinica de Morelia, S.C.	Morelia
Poland	Centrum Osteoporozy i Chorob KKostno-Stawowych Daniluk Clinical Research Centre	Bialystok
Poland	NZOZ Osteo-Medic sc A. Racewicz, J. Supronik	Bialystok
Poland	Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela	Bydgoszcz
Poland	NZOZ Centrum Medyczne ProMiMed	Krakow
Poland	Zespol Poradni Specjalistycznych REUMED sp. Zo.o	Lublin
Poland	ARS Rheumatica	Warszawa
Poland	Rheuma Medicus Zaktad Opieki Zdrowotnej Relle Brkolozka	Wraszawa
United States	Austin Rheumatology Research PA	Austin	Texas
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Center for Arthritis & Rheumatic Disease, P.C.	Chesapeake	Virginia
United States	Mountain State Clinical Research	Clarksburg	West Virginia
United States	Arthritis Associates of Colorado Springs	Colorado Springs	Colorado
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Center for Arthritis and Osteoporosis	Elizabethtown	Kentucky
United States	PMG Research	Hickory	North Carolina
United States	The Talbert Group	Huntington Beach	California
United States	Rheumatology Consultants, PLLC	Knoxville	Tennessee
United States	University of California San Diego	La Jolla	California
United States	Illinois Bone & Joint	Morton Grove	Illinois
United States	Health Research of Oklahoma	Oklahoma City	Oklahoma
United States	Arthritis Associates	Orlando	Florida
United States	Desert Medical Advances	Palm Desert	California
United States	Pacific Arthritis Center Medical Group	Santa Maria	California
United States	Deerbrook Medical Asssociates	Vernon Hills	Illinois
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Clincal Research Center of Reading	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving American College of Rheumatology Criteria 20 (ACR 20) response		Week 12
Primary	Trough plasma concentration of ASP015K and metabolite(s)		up to Week 12
Secondary	Percentage of subjects achieving ACR 50 response		Week 12
Secondary	Percentage of subjects achieving ACR 70 response		Week 12
Secondary	Change from baseline in Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP)		Baseline and Week 12

External Links

•   Link to results on the Astellas Clinical Study Results website