A Randomized, Double Blind, Placebo Controlled Study to Investigate the Safety and Tolerability and Clinical Activity of 28 Days of Oral Repeat Dosing With GW856553 at 7.5mg BID in Subjects With Active Rheumatoid Arthritis on Stable Anti-rheumatic Therapy.

GlaxoSmithKline1 site in 1 country57 target enrollmentOctober 2006

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Arthritis, Rheumatoid
Sponsor: GlaxoSmithKline
Enrollment: 57
Locations: 1
Primary Endpoint: Disease activity score based on 28 joint count (DAS28) at the end of the study.
Status: Completed
Last Updated: 10 years ago

This study is designed to look at the safety, tolerability and effectiveness of 28 days of dosing of GW856553 in rheumatoid arthritis patients.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

January 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Responsible Party

Sponsor

Disease activity score based on 28 joint count (DAS28) at the end of the study.

Time Frame: at the end of the study.

Population pharmacokinetics after 56 days(after 56 days)
Gadolinium enhanced MRI scans after 56 days.(after 56 days.)
Plasma biomarkers after 56 days.(after 56 days)
Adverse events, vitals signs, ECGs and clinical lab tests after 56 days.(after 56 days.)