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

Tracking Information
First Received Date ^ICMJE	March 31, 2008
Last Updated Date	July 7, 2009
Start Date ^ICMJE	March 2008
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 31, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00650767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 31, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Orally Active, Small Molecule Inhibitor of MEK1 and MEK2 in Patients With Active Rheumatoid Arthritis
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: ARRY-438162 Other: Placebo
Study Arms / Comparison Groups	Experimental: 10 mg BID Experimental: 40 mg QD Experimental: 20 mg BID
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	200
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Brazil, Hungary, Peru, Poland, Romania

Administrative Information
NCT ID ^ICMJE	NCT00650767
Responsible Party	Adam James, Clinical Program Manager, Array BioPharma
Study ID Numbers ^ICMJE	ARRAY-162-201
Study Sponsor ^ICMJE	Array BioPharma
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Array BioPharma
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP