Orally Active, Small Molecule Inhibitor of MEK1 and MEK2 in Patients With Active Rheumatoid Arthritis - Full Text View

Sponsor:	Array BioPharma
Information provided by:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00650767

Purpose

This is a Phase 2, randomized, double-blind, multicenter, placebo-controlled, parallel-group, 12-week treatment trial of a MEK inhibitor with oral delivery in patients with active RA on stable doses of MTX for ≥6 weeks. Prior biological therapy is not allowed. Other therapies that are currently effective and tolerated should not be discontinued just to participate in this trial. Approximately 200 patients will be enrolled in this study. All patients will be randomized to 1 of 3 dosing regimens of ARRY-438162 (10 mg BID, 40 mg QD, 20 mg BID) or placebo.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: ARRY-438162 Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of ARRY-438162 Administered Orally Daily in Patients With Active Rheumatoid Arthritis Incompletely Responsive to Methotrexate

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

To compare the efficacy of 3 dose levels of ARRY-438162 (10 mg BID, 40 mg QD, and 20 mg BID) versus placebo, administered over 12 weeks for the treatment of the signs and symptoms of patients with Rheumatoid Arthritis on stable doses of methotrexate. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To determine the American College of Rheumatology 20% (ACR20) best response rate at week 12 of patients treated with any well-tolerated dose. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of ARRY-438162 in patients with active Rheumatoid Arthritis on stable doses of methotrexate (> 10 mg <25 mg) for > 6 weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the pharmacokinetic profiles of multiple doses of ARRY-438162 administered for 12 weeks to patients with active Rheumatoid Arthritis on stable doses of methotrexate. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the dose-and concentration- response of ARRY-438162 against measures of disease activity through 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
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
1: Experimental 10 mg BID	Drug: ARRY-438162 10 or 20 mg tablet
2: Experimental 40 mg QD	Drug: ARRY-438162 10 or 20 mg tablet
3: Experimental 20 mg BID	Drug: ARRY-438162 10 or 20 mg tablet
4: Placebo Comparator	Other: Placebo tablet

Eligibility

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

Criteria

Inclusion Criteria:

Provided written informed consent and is willing to comply to scheduled visits, treatment plans, laboratory tests, and other trial procedures.
Has received a stable dose of methotrexate for > 6 weeks prior to screening and is willing to continue on this regimen for duration of study.
Has never received biological agents for the treatment of RA and agree not to do so for duration of study.
Has been diagnosed with RA prior to the screening visit.
Has received a stable dose of folate for > 6 weeks and is willing to continue in this regimen for the duration of the study.
Additional Inclusion Criteria Apply

Exclusion Criteria:

Patients with a 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.
Patients with a history of: severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with RA.
Additional Exclusion Criteria Apply

Contacts and Locations

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

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Locations

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

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Responsible Party:	Array BioPharma ( Adam James, Clinical Program Manager )
Study ID Numbers:	ARRAY-162-201
Study First Received:	March 31, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00650767 History of Changes
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:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2009