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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

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01554696

Astellas Study ID

The unique identification code given by the study sponsor.

015K-CL-RA21

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2011-006018-15

Follow Trial

Condition

Rheumatoid Arthritis

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jul 2012 - Feb 2014

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

379

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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

MHAT Burgas

Burgas, Bulgaria, 8000

Health Research of Oklahoma

Oklahoma City, United States, 73103

Clincal Research Center of Reading

Wyomissing, United States, 19610

MHAT "Sv. Ivan Rilski"

Sofia, Bulgaria, 1612

Zespol Poradni Specjalistycznych REUMED sp. Zo.o

Lublin, Poland, 20-582

Centrum Osteoporozy i Chorob KKostno-Stawowych Daniluk Clinical Research Centre

Bialystok, Poland, 15-461

NZOZ Osteo-Medic sc A. Racewicz, J. Supronik

Bialystok, Poland, 15-351

University of California San Diego

LaJolla, United States, 92093-0943

Cliditer S.A. de C.V.Huerta S.I.

Mexico D.F., Mexico, 6700

Centro Integral De Reumatologia E Inmunologia

Bogota, Colombia

PMG Research

Hickory, United States, 28602

PV-MEDICAL s.r.o.

Zlin, Czech Republic, 760 01

Centro Integral de Reumatología del Caribe S.A.S

Barranquilla, Colombia

MHAT Plovdiv AD

Plovdiv, Bulgaria, 4003

The Center for Rheumatology and Bone Research

Wheaton, United States, 20902

MEDICAL PLUS, s.r.o. or REVMACENTRUM UH, s.r.o.

Uherske Hradiste, Czech Republic, 68601

Rethy Pal Korhaz es Rendelointezet

Bekescsaba, Hungary, 5600

Arthritis Associates of Colorado Springs

Colorado Springs, United States, 80910

The Talbert Group

Huntington Beach, United States, 92646

Desert Medical Advances

Palm Desert, United States, 92260

Revita Clinic Rheumatology

Budapest, Hungary, 1027

Achieve Clinical Research, LLC

Birmingham, United States, 35216

Morales Vargas Centro de Investigacion, SC Rheumatology

Leon, Mexico, 37000

Szpital Uniwersytecki nr. 2 im. Dr. Jana Biziela

Bydgoszcz, Poland, 85-168

Center for Arthritis & Rheumatic Disease, P.C.

Chesapeake, United States, 23320

MEDICITY SAS

Bucaramanga, Colombia

NZOZ Centrum Medyczne ProMiMed

Krakow, Poland, 31-637

Illinois Bone & Joint

Morton Grove, United States, 60053

SERVIMED E.U.

Bucaramanga, Colombia

Center for Arthritis and Osteoporosis

Elizabethtown, United States, 42701

Hospital Civil de Guadalajara Fray Antonio Alcalde Gutierrez

Guadalajara, Mexico, 44280

Deerbrook Medical Asssociates

Vernon Hills, United States, 60061

Centro de medicina Interna Julian Coronel

Cali, Colombia

Mountain State Clinical Research

Clarksburg, United States, 26301

Austin Rheumatology Research PA

Austin, United States, 78705

Hospital Erasme

Brussels, Belgium, 1070

IPS Rodrigo Botero SAS

Medellin, Colombia, 5001000

Kenezy Hospital Institute of Clinical Pharmacology

Debrecen, Hungary, H-4043

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfured, Hungary, H-8230

Pacific Arthritis Center Medical Group

Santa Maria, United States, 93454

Arthritis Associates

Orlando, United States, 32804

Centro Integral en Reumatologia, SA de CV

Guadalajara, Mexico, 44158

Revmatologicky ustav

Praha 2, Czech Republic, 128 50

Dr Javier Orozco Alcala Private Doctor´s office

Guadalajara, Mexico, 44650

Rheumatology Consultants, PLLC

Knoxville, United States, 37909-1907

Rheuma Medicus Zaktad Opieki Zdrowotnej Relle Brkolozka

Wraszawa, Poland, 02-118

ARS Rheumatica

Warszawa, Poland, 02-653

Altoona Center for Clinical Research

Duncansville, United States, 16635

Moliere Hospital

Brussels, Belgium, 1190

Centro de Investigacion Clinica de Morelia, S.C.

Morelia, Mexico, 58070

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