A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Array BioPharma

ClinicalTrials.gov Identifier:

NCT00650767

First received: March 31, 2008

Last updated: August 29, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 31, 2008
Last Updated Date	August 29, 2012
Start Date ^ICMJE	March 2008
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 29, 2012)	Assess the efficacy of 3 dose levels of the study drug in terms of American College of Rheumatology 20% (ACR20) response rate. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: March 31, 2008)	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 ] 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 ]
Change History	Complete list of historical versions of study NCT00650767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 29, 2012)	Measure the exposure of study drug in terms of plasma concentrations. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original 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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Official Title ^ICMJE	Not Provided
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: ARRY-438162, MEK inhibitor; oral multiple dose, single schedule Drug: Placebo; oral matching placebo
Study Arm (s)	Experimental: ARRY-438162 (Schedule 1) Intervention: Drug: ARRY-438162, MEK inhibitor; oral Experimental: ARRY-438162 (Schedule 2) Intervention: Drug: ARRY-438162, MEK inhibitor; oral Experimental: ARRY-438162 (Schedule 3) Intervention: Drug: ARRY-438162, MEK inhibitor; oral Placebo Comparator: Placebo Intervention: Drug: Placebo; oral
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	201
Completion Date	July 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
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 Number ^ICMJE	NCT00650767
Other Study ID Numbers ^ICMJE	ARRAY-162-201
Has Data Monitoring Committee	Yes
Responsible Party	Array BioPharma
Study Sponsor ^ICMJE	Array BioPharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Array BioPharma
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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