A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
This study has been completed.
Sponsor:
Array BioPharma
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 May 19, 2013