A Study To Investigate The Effect Of 28 Days Of Dosing With GW856553 On Patients With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT00393146
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-26
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Santiago de Compostela, Spain