A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

Array BioPharma

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; oral; Drug: ARRY-438162, MEK inhibitor; oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650767

ARRAY-162-201

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 4 patient groups, including a placebo group

ARRY-438162 (Schedule 1)

Experimental group

Treatment:

Drug: ARRY-438162, MEK inhibitor; oral

ARRY-438162 (Schedule 2)

Experimental group

Treatment:

Drug: ARRY-438162, MEK inhibitor; oral

ARRY-438162 (Schedule 3)

Experimental group

Treatment:

Drug: ARRY-438162, MEK inhibitor; oral

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo; oral