A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00650767
First received: March 31, 2008
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: ARRY-438162, MEK inhibitor; oral
Drug: Placebo; oral
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Assess the efficacy of 3 dose levels of the study drug in terms of American College of Rheumatology 20% (ACR20) response rate. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure the exposure of study drug in terms of plasma concentrations. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-438162 (Schedule 1) Drug: ARRY-438162, MEK inhibitor; oral
multiple dose, single schedule
Experimental: ARRY-438162 (Schedule 2) Drug: ARRY-438162, MEK inhibitor; oral
multiple dose, single schedule
Experimental: ARRY-438162 (Schedule 3) Drug: ARRY-438162, MEK inhibitor; oral
multiple dose, single schedule
Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key 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.

Key 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650767

Locations
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Argentina
Hospital Britanico
Buenos Aires, Argentina
CEMIC
Buenos Aires, Argentina
Asistencia Integral en Reumatologia
Buenos Aires, Argentina
CER San Juan
San Juan, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Argentina
Centro de Investigaciones Clinicas del Litoral SRL
Santa Fe, Argentina
Brazil
Médicos Unidos Ltda.
Goiânia, GO, Brazil, 74110-120
CETI - Hospital das Clínicas da Universidade Federal do Paraná
Curitiba, PR, Brazil, 80060
Hospital São Lucas da da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, RS, Brazil, 90610-000
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-003
Instituto de Medicina Avançada (IMA Brasil)
São Paulo, SP, Brazil, 05437-010
Hospital São Paulo / Instituto Paulista de Reumatologia
São Paulo, SP, Brazil, 04026-000
Hospital Heliópolis
São Paulo, SP, Brazil, 04230-000
Hungary
Synexus Ltd Hungary
Budapest, Hungary
Budai Irgalmasrendi Kórház - Allergólógia és Immunológia
Budapest, Hungary
Békés Megyei Pándy Kálmán Kórház - Rheumatology
Gyula, Hungary
Mozgasszervi Rehabilitacios Kozpont
Mezőkövesd, Hungary
MÁV Kórház - Clinical Pharmacology
Szolnok, Hungary
Vas Megyei Markusovszky Korhaz Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház, Zártkörűen Működő Nonprofit Részvénytársaság - Rheumatology
Szombathely, Hungary
Fejér Megyei Szent György Kórház - Rheumatology
Székesfehérvár, Hungary
Peru
Instituto de Investigacion y Seguridad Medica EIRL
Arequipa, Peru
Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia
Lima, Peru
Hospital Maria Auxiliadora - Centro de Investigaciones Medicas
Lima, Peru
Clinica San Felipe - Centro de Estudios Clinicos CGYM
Lima, Peru
Poland
Centrum Osteoporozy i Chorób Kostno-Stawowych
Bialystok, Poland
Wojewódzki Szpital Zespolony - Oddział Reumatologiczny
Elblag, Poland
Centrum Leczenia Chorob Cywilizacyjnych
Gdynia, Poland
NZOZ Reumed
Lublin, Poland
Centrum Leczenia Chorob Cywilizacyjnych
Warszawa, Poland
Synexus SCM Sp. z o.o.
Wroclaw, Poland
Romania
Spitalul Clinic "Sf, Maria"
Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta
Cluj-Napoca, Romania
Spitalul Clinic Judetean de Urgenta
Targu Mures, Romania
Cabinet Medical "Prof. Dr. Miorara Banciu"
Timisoara, Romania
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00650767     History of Changes
Other Study ID Numbers: ARRAY-162-201
Study First Received: March 31, 2008
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research
Hungary: National Institute of Pharmacy
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ethics Committee
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Romania: Ministry of Public Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014