A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 19, 2005
Last updated: October 9, 2008
Last verified: October 2008
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 Intervention
Rheumatoid Arthritis
Procedure: Power doppler ultrasonography
Procedure: High frequency ultrasonography
Procedure: Exhaled nitric oxide assessment

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 48
Study Start Date: October 2004
Intervention Details:
    Procedure: Power doppler ultrasonography Procedure: High frequency ultrasonography
    Other Names:
    • Exhaled nitric oxide assessment
    • Power doppler ultrasonography
    Procedure: Exhaled nitric oxide assessment

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00242853

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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00242853     History of Changes
Other Study ID Numbers: RA4102651 
Study First Received: October 19, 2005
Last Updated: October 9, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Rheumatoid arthritis
Exhaled NO

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

ClinicalTrials.gov processed this record on May 25, 2016