A Study of ARRY-438162 in Patients With Rheumatoid

A Study of ARRY-438162 in Patients With Rheumatoid

A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Status: Completed
Study Phase: Phase 2
Start Date: March 2008 | Completion Date: July 2009
Condition(s): Rheumatoid Arthritis
Overview
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate
the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid
arthritis in patients on stable doses of methotrexate, and to further evaluate the
safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil,
Hungary, Peru, Poland and Romania will be enrolled in this study.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver,
Investigator, Outcomes Assessor), Primary Purpose: Treatment
Investigator Details
Lead Sponsor: Array BioPharma
Trial Location Details
Facility: Spartanburg Medical Research Spartanburg, United States
Facility: Asistencia Integral en Reumatologia Buenos Aires, Argentina
Facility: CEMIC Buenos Aires, Argentina
Facility: Hospital Britanico Buenos Aires, Argentina
Facility: CER San Juan San Juan, Argentina
Facility: Centro Medico Privado de Reumatologia San Miguel de Tucumán, Argentina
Facility: Centro de Investigaciones Clinicas del Litoral SRL Santa Fe, Argentina
Facility: Médicos Unidos Ltda. Goiânia, Brazil
Facility: CETI - Hospital das Clínicas da Universidade Federal do Paraná Curitiba, Brazil
Facility: Hospital de Clínicas de Porto Alegre Porto Alegre, Brazil
Facility: Hospital São Lucas da da Pontifícia Universidade Católica do Rio Grande
do Sul Porto Alegre, Brazil
Facility: Hospital São Paulo / Instituto Paulista de Reumatologia São Paulo, Brazil
Facility: Hospital Heliópolis São Paulo, Brazil
Facility: Instituto de Medicina Avançada (IMA Brasil) São Paulo, Brazil
Facility: Budai Irgalmasrendi Kórház - Allergólógia és Immunológia Budapest, Hungary
Facility: Synexus Ltd Hungary Budapest, Hungary
Facility: Békés Megyei Pándy Kálmán Kórház - Rheumatology Gyula, Hungary
Facility: Mozgasszervi Rehabilitacios Kozpont Mez?kövesd, Hungary
Facility: MÁV Kórház - Clinical Pharmacology Szolnok, Hungary
Facility: Vas Megyei Markusovszky Korhaz Lajos Általános, Rehabilitációs és
Gyógyfürdő Kórház, Egyetemi Oktató Kórház, Zártkörűen Működő Nonprofit
Részvénytársaság - Rheumatology Szombathely, Hungary
Facility: Fejér Megyei Szent György Kórház - Rheumatology Székesfehérvár, Hungary
Facility: Instituto de Investigacion y Seguridad Medica EIRL Arequipa, Peru
Facility: Clinica San Felipe - Centro de Estudios Clinicos CGYM Lima, Peru
Facility: Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia Lima, Peru
Facility: Hospital Maria Auxiliadora - Centro de Investigaciones Medicas Lima, Peru
Facility: Centrum Osteoporozy i Chorób Kostno-Stawowych Bialystok, Poland
Facility: Wojewódzki Szpital Zespolony - Oddział ReumatologicznyElblag, Poland
Facility: Centrum Leczenia Chorob Cywilizacyjnych Gdynia, Poland
Facility: NZOZ Reumed Lublin, Poland
Facility: Centrum Leczenia Chorob Cywilizacyjnych Warszawa, Poland
Facility: Synexus SCM Sp. z o.o. Wroclaw, Poland
Facility: Spitalul Clinic "Sf, Maria" Bucuresti, Romania
Facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Romania
Facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Romania
Facility: Cabinet Medical "Prof. Dr. Miorara Banciu" Timisoara, Romania
Interventions
Drug: ARRY-438162, MEK inhibitor; oral
multiple dose, single schedule
Drug: Placebo; oral
matching placebo
Information Source
ID Number: ARRAY-162-201
NCT Identifier: NCT00650767
Health Authority: Array
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT00650767
ClinicalTrials.gov processed this data on September 29, 2016
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