A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

NCT00650767 | Completed Phase 2 Results DMC

• 1 other identifier: ARRAY-162-201
• Study Type: interventional
• Target: 201
• Locations: 7 countries
• Sites: 35

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology 20% (ACR20) Response Rate at Week 12

  The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

  Week 12

Secondary Outcomes (123)

• American College of Rheumatology 20% (ACR20) Response Rate at Week 1

  Week 1

• American College of Rheumatology 20% (ACR20) Response Rate at Week 2

  Week 2

• American College of Rheumatology 20% (ACR20) Response Rate at Week 4

  Week 4

• American College of Rheumatology 20% (ACR20) Response Rate at Week 8

  Week 8

• American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)

  Week 16 (Follow-up)

Study Arms (4)

ARRY-438162 (Schedule 1)

EXPERIMENTAL

Drug: ARRY-438162, MEK inhibitor; oral

ARRY-438162 (Schedule 2)

EXPERIMENTAL

Drug: ARRY-438162, MEK inhibitor; oral

ARRY-438162 (Schedule 3)

EXPERIMENTAL

Drug: ARRY-438162, MEK inhibitor; oral

Placebo

PLACEBO COMPARATOR

Drug: Placebo; oral

Interventions

ARRY-438162, MEK inhibitor; oral DRUG

multiple dose, single schedule

ARRY-438162 (Schedule 1); ARRY-438162 (Schedule 2); ARRY-438162 (Schedule 3)

Placebo; oral DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Array Biopharma, now a wholly owned subsidiary of Pfizer: lead

Study Sites (35)

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Asistencia Integral en Reumatologia

Buenos Aires, Argentina

Location

CEMIC

Buenos Aires, Argentina

Location

Hospital Britanico

Buenos Aires, Argentina

Location

CER San Juan

San Juan, Argentina

Location

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Argentina

Location

Centro de Investigaciones Clinicas del Litoral SRL

Santa Fe, Argentina

Location

Médicos Unidos Ltda.

Goiânia, Goiás, 74110-120, Brazil

Location

CETI - Hospital das Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, 80060, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital São Paulo / Instituto Paulista de Reumatologia

São Paulo, São Paulo, 04026-000, Brazil

Location

Hospital Heliópolis

São Paulo, São Paulo, 04230-000, Brazil

Location

Instituto de Medicina Avançada (IMA Brasil)

São Paulo, São Paulo, 05437-010, Brazil

Location

Budai Irgalmasrendi Kórház - Allergólógia és Immunológia

Budapest, Hungary

Location

Synexus Ltd Hungary

Budapest, Hungary

Location

Békés Megyei Pándy Kálmán Kórház - Rheumatology

Gyula, Hungary

Location

Mozgasszervi Rehabilitacios Kozpont

Mezőkövesd, Hungary

Location

Fejér Megyei Szent György Kórház - Rheumatology

Székesfehérvár, Hungary

Location

MÁV Kórház - Clinical Pharmacology

Szolnok, Hungary

Location

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

Szombathely, Hungary

Location

Instituto de Investigacion y Seguridad Medica EIRL

Arequipa, Peru

Location

Clinica San Felipe - Centro de Estudios Clinicos CGYM

Lima, Peru

Location

Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia

Lima, Peru

Location

Hospital Maria Auxiliadora - Centro de Investigaciones Medicas

Lima, Peru

Location

Centrum Osteoporozy i Chorób Kostno-Stawowych

Bialystok, Poland

Location

Wojewódzki Szpital Zespolony - Oddział Reumatologiczny

Elblag, Poland

Location

Centrum Leczenia Chorob Cywilizacyjnych

Gdynia, Poland

Location

NZOZ Reumed

Lublin, Poland

Location

Centrum Leczenia Chorob Cywilizacyjnych

Warsaw, Poland

Location

Synexus SCM Sp. z o.o.

Wroclaw, Poland

Location

Spitalul Clinic "Sf, Maria"

Bucharest, Romania

Location

Spitalul Clinic Judetean de Urgenta

Cluj-Napoca, Romania

Location

Spitalul Clinic Judetean de Urgenta

Târgu Mureş, Romania

Location

Cabinet Medical "Prof. Dr. Miorara Banciu"

Timișoara, Romania

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Array BioPharma, Inc.

clinicaltrials@arraybiopharma.com

303-381-6604

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 1, 2020
• Results First Posted: November 7, 2016

Record last verified: 2020-11

Locations

BR (7); PL (6); RO (4); PE (4); AR (6); US (1); HU (7)