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

November 1, 2012 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • GSK Investigational Site
      • Sofia, Bulgaria, 1431
        • GSK Investigational Site
      • Sofia, Bulgaria, 1233
        • GSK Investigational Site
  • Germany
      • Hamburg, Germany, 21075
        • GSK Investigational Site
    • Bayern
      • Erlangen, Bayern, Germany, 91056
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80639
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bad Bramstedt, Schleswig-Holstein, Germany, 24576
        • GSK Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Santiago de Compostela, Spain, 15706
        • GSK Investigational Site
      • Sevilla, Spain, 41071
        • GSK Investigational Site
  • Sweden
      • Linkoeping, Sweden, SE-582 25
        • GSK Investigational Site
      • Uppsala, Sweden, SE-753 23
        • GSK Investigational Site
  • Ukraine
      • Donetsk, Ukraine, 83045
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61002
        • GSK Investigational Site
      • Kiev, Ukraine, 01030
        • GSK Investigational Site
      • Kyiv, Ukraine, 03680
        • GSK Investigational Site
      • Lviv, Ukraine, 79010
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 4, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA3103730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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