A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

October 9, 2008 updated by: GlaxoSmithKline

An Enabling Study to Investigate the Correlation of Biomarkers of the Activity of Inducible Nitric Oxide Synthase (iNOS) With Disease Activity and Treatment Response in Patients With Rheumatoid Arthritis(RA)

This study is being conducted to validate various biomarkers in patients with RA with varying levels of disease severity. Subjects with a diagnosis of rheumatoid arthritis (RA) will be included as controls. The sudy will measure the baseline levels and the intra- and inter-subject variability of exhaled nitric oxide (NO) in patients with inactive/mild and moderate/severe RA on stable therapy or during a course glucocorticoids. In addition exhaled NO levels will be correlated with intra-articular inflammation (power Doppler ultrasonography) as well as markers of systemic inflammation (CRP, ESR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

48

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

  • United Kingdom
      • London, United Kingdom, W6 8LH
        • 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of rheumatoid or osteo-arthritis.
  • Weight greater than 45kg (females) or 50kg (males) but not overweight.
  • Non-smokers.
  • Taking stable anti-inflammatory medication for Rheumatoid Arthritis (RA) or Osteoarthritis (OA) for at least 8 weeks.

Exclusion criteria:

  • Taking regular doses of glucocorticoid medication (greater than 5mg/day).
  • Currently taking biological treatment for RA.
  • Recent participation in another clinical trial.

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

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

October 1, 2004

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 13, 2008

Last Update Submitted That Met QC Criteria

October 9, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA4102651

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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