A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242853
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : October 13, 2008
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Brief Summary:
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).

Condition or disease Intervention/treatment
Rheumatoid Arthritis Osteoarthritis Procedure: Power doppler ultrasonography Procedure: High frequency ultrasonography Procedure: Exhaled nitric oxide assessment

Study Type : Observational
Enrollment : 48 participants
Time Perspective: Prospective
Official Title: 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)
Study Start Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Procedure: Power doppler ultrasonography Procedure: High frequency ultrasonography
    Other Names:
    • Exhaled nitric oxide assessment
    • Power doppler ultrasonography
    Procedure: Exhaled nitric oxide assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242853

United Kingdom
GSK Investigational Site
London, United Kingdom, W6 8LH
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00242853     History of Changes
Other Study ID Numbers: RA4102651
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
Rheumatoid arthritis
Exhaled NO

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents