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A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

NCT ID: NCT00650767

Last Updated: 2020-12-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARRY-438162 (Schedule 1)

Group Type EXPERIMENTAL

ARRY-438162, MEK inhibitor; oral

Intervention Type DRUG

multiple dose, single schedule

ARRY-438162 (Schedule 2)

Group Type EXPERIMENTAL

ARRY-438162, MEK inhibitor; oral

Intervention Type DRUG

multiple dose, single schedule

ARRY-438162 (Schedule 3)

Group Type EXPERIMENTAL

ARRY-438162, MEK inhibitor; oral

Intervention Type DRUG

multiple dose, single schedule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo; oral

Intervention Type DRUG

matching placebo

Interventions

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ARRY-438162, MEK inhibitor; oral

multiple dose, single schedule

Intervention Type DRUG

Placebo; oral

matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
* Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
* Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
* No prior use of biological agents for the treatment of rheumatoid arthritis.
* Additional criteria exist.

Exclusion Criteria

* Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
* A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
* Additional criteria exist.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Asistencia Integral en Reumatologia

Buenos Aires, , Argentina

Site Status

CEMIC

Buenos Aires, , Argentina

Site Status

Hospital Britanico

Buenos Aires, , Argentina

Site Status

CER San Juan

San Juan, , Argentina

Site Status

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, , Argentina

Site Status

Centro de Investigaciones Clinicas del Litoral SRL

Santa Fe, , Argentina

Site Status

Médicos Unidos Ltda.

Goiânia, Goiás, Brazil

Site Status

CETI - Hospital das Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, Brazil

Site Status

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital São Lucas da da Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital São Paulo / Instituto Paulista de Reumatologia

São Paulo, São Paulo, Brazil

Site Status

Hospital Heliópolis

São Paulo, São Paulo, Brazil

Site Status

Instituto de Medicina Avançada (IMA Brasil)

São Paulo, São Paulo, Brazil

Site Status

Budai Irgalmasrendi Kórház - Allergólógia és Immunológia

Budapest, , Hungary

Site Status

Synexus Ltd Hungary

Budapest, , Hungary

Site Status

Békés Megyei Pándy Kálmán Kórház - Rheumatology

Gyula, , Hungary

Site Status

Mozgasszervi Rehabilitacios Kozpont

Mezőkövesd, , Hungary

Site Status

Fejér Megyei Szent György Kórház - Rheumatology

Székesfehérvár, , Hungary

Site Status

MÁV Kórház - Clinical Pharmacology

Szolnok, , Hungary

Site Status

Vas Megyei Markusovszky Korhaz Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház, Zártkörűen Működő Nonprofit Részvénytársaság - Rheumatology

Szombathely, , Hungary

Site Status

Instituto de Investigacion y Seguridad Medica EIRL

Arequipa, , Peru

Site Status

Clinica San Felipe - Centro de Estudios Clinicos CGYM

Lima, , Peru

Site Status

Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia

Lima, , Peru

Site Status

Hospital Maria Auxiliadora - Centro de Investigaciones Medicas

Lima, , Peru

Site Status

Centrum Osteoporozy i Chorób Kostno-Stawowych

Bialystok, , Poland

Site Status

Wojewódzki Szpital Zespolony - Oddział Reumatologiczny

Elblag, , Poland

Site Status

Centrum Leczenia Chorob Cywilizacyjnych

Gdynia, , Poland

Site Status

NZOZ Reumed

Lublin, , Poland

Site Status

Centrum Leczenia Chorob Cywilizacyjnych

Warsaw, , Poland

Site Status

Synexus SCM Sp. z o.o.

Wroclaw, , Poland

Site Status

Spitalul Clinic "Sf, Maria"

Bucharest, , Romania

Site Status

Spitalul Clinic Judetean de Urgenta

Cluj-Napoca, , Romania

Site Status

Spitalul Clinic Judetean de Urgenta

Târgu Mureş, , Romania

Site Status

Cabinet Medical "Prof. Dr. Miorara Banciu"

Timișoara, , Romania

Site Status

Countries

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United States Argentina Brazil Hungary Peru Poland Romania

Other Identifiers

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ARRAY-162-201

Identifier Type: -

Identifier Source: org_study_id