At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 201 enrolled
Drug / intervention
ARRY-438162, MEK inhibitor; oral +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Array Biopharma, now a wholly owned subsidiary of Pfizer·interventional·Posted Apr 2, 2008·Updated Dec 1, 2020
In Brief
A Phase 2 clinical trial evaluating ARRY-438162, MEK inhibitor; oral and Placebo; oral for Rheumatoid Arthritis. Completed, enrolled 201 participants across 35 sites in 7 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Brazil, Hungary, Peru, Poland, Romania, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedApr 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedApr 2, 2008
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago
Interventions
ARRY-438162, MEK inhibitor; oraldrug
multiple dose, single schedule
Placebo; oraldrug
matching placebo