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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00256919

First received: November 21, 2005

Last updated: September 13, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 21, 2005

Last Updated Date

September 13, 2012

Start Date ^ICMJE

November 2005

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

C-reactive protein (CRP) levels 72 hours post-dose. [ Time Frame: 72 hours post-dose. ]

Original Primary Outcome Measures ^ICMJE

Determine dose-response relationship for a range of doses (7.5, 20 and 60mg) of GW856553 on levels of a blood protein (CRP) associated with rheumatoid arthritis

Change History

Complete list of historical versions of study NCT00256919 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

C-reactive protein (CRP) levels 24 and 48 hours post-dose [ Time Frame: 24 and 48 hours post-dose ]

Original Secondary Outcome Measures ^ICMJE

Determine plasma drug concentrations to allow characterisation of the action of the body on the drug.

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Arthritis, Rheumatoid

Intervention ^ICMJE

Drug: GW856553

Other Name: GW856553

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bulgaria, Germany, Spain, Sweden, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT00256919

Other Study ID Numbers ^ICMJE

RA3103730

Has Data Monitoring Committee

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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