Expired Study
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Spartanburg, South Carolina 29303


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

ARRAY-162-201


NCT ID:

NCT00650767


Secondary ID:


Study Acronym:


Brief Title:

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


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 M


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Array BioPharma


Oversight 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


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Study Dates

Start Date:March 2008
Completion Date:July 2009
Completion Type:Actual
Primary Completion Date:July 2009
Primary Completion Type:Actual
Verification Date:December 2009
Last Changed Date:December 9, 2009
First Received Date:March 31, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To evaluate the dose-and concentration- response of ARRY-438162 against measures of disease activity through 12 weeks of treatment
Time Frame:12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:ARRY-438162
Description:10 or 20 mg tablet
Arm Name:1
Intervention Type:Other
Name:Placebo
Description:tablet
Arm Name:4

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:4
Study Arm Type:Experimental
Arm Name:3
Description:20 mg BID
Study Arm Type:Experimental
Arm Name:2
Description:40 mg QD
Study Arm Type:Experimental
Arm Name:1
Description:10 mg BID

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Array BioPharma

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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