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Sponsored by: |
Array BioPharma |
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Information provided by: | Array BioPharma |
ClinicalTrials.gov Identifier: | NCT00650767 |
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 |
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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 |
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 |
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1: Experimental
10 mg BID
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Drug: ARRY-438162
10 or 20 mg tablet
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2: Experimental
40 mg QD
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Drug: ARRY-438162
10 or 20 mg tablet
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3: Experimental
20 mg BID
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Drug: ARRY-438162
10 or 20 mg tablet
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4: Placebo Comparator |
Other: Placebo
tablet
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |