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A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00242853
First received: October 19, 2005
Last updated: October 9, 2008
Last verified: October 2008
History of Changes
  Purpose

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
Osteoarthritis
 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:

U.S. FDA Resources

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
    • High frequency ultrasonography
    Procedure: Exhaled nitric oxide assessment
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242853

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

No publications provided

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:
iNOS
Rheumatoid arthritis
Exhaled NO

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
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
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013