Who is sponsoring NCT00650767?

NCT00650767 is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

What condition does NCT00650767 study?

NCT00650767 studies Rheumatoid Arthritis.

What drugs are being tested in NCT00650767?

Interventions: ARRY-438162, MEK inhibitor; oral, Placebo; oral.

What is the status of NCT00650767?

NCT00650767 is currently COMPLETED.

Last reviewed 2020-11-15 · How we verify

A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

NCT00650767 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Array Biopharma, now a wholly owned subsidiary of Pfizer
Phase	Phase 2
Status	COMPLETED
Enrolment	201
Start date	2008-03
Completion	2009-07

Conditions

Rheumatoid Arthritis

Interventions

ARRY-438162, MEK inhibitor; oral
Placebo; oral

Primary outcomes

American College of Rheumatology 20% (ACR20) Response Rate at Week 12 — Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.

Countries

United States, Argentina, Brazil, Hungary, Peru, Poland, Romania