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NCT00256919 Clinical Trial

Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)

Arthritis, Rheumatoid Clinical Trial

Official title:
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00256919
Other study ID # RA3103730
Secondary ID
Status Completed
Phase Phase 2
First received November 21, 2005
Last updated November 1, 2012
Start date November 2005
Est. completion date November 2006

Study information
Verified date October 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.

- Must have 3 or more swollen or 3 or more tender/painful joints at screening.

- Must be on stable weekly methotrexate (2.5mg-25mg) for at least eight weeks prior to screening.

Exclusion criteria:

- Must not be morbidly obese.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GW856553

Locations
Country Name City State
Bulgaria GSK Investigational Site Plovdiv
Bulgaria GSK Investigational Site Sofia
Bulgaria GSK Investigational Site Sofia
Germany GSK Investigational Site Bad Bramstedt Schleswig-Holstein
Germany GSK Investigational Site Erlangen Bayern
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Muenchen Bayern
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Santiago de Compostela
Spain GSK Investigational Site Sevilla
Sweden GSK Investigational Site Linkoeping
Sweden GSK Investigational Site Uppsala
Ukraine GSK Investigational Site Donetsk
Ukraine GSK Investigational Site Kharkiv
Ukraine GSK Investigational Site Kiev
Ukraine GSK Investigational Site Kyiv
Ukraine GSK Investigational Site Lviv

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Bulgaria,  Germany,  Spain,  Sweden,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary C-reactive protein (CRP) levels 72 hours post-dose. 72 hours post-dose.
Secondary C-reactive protein (CRP) levels 24 and 48 hours post-dose 24 and 48 hours post-dose
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