A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

This study has been completed.

First Received: October 19, 2005 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00242853

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:	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:

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis Ultrasound

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	48
Study Start Date:	October 2004

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

Keywords provided by GlaxoSmithKline:

iNOS
Rheumatoid arthritis
Exhaled NO

Study placed in the following topic categories:

Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Autoimmune Diseases
Osteoarthritis
Joint Diseases
Arthritis, Rheumatoid
Anti-Asthmatic Agents
Cardiovascular Agents

Rheumatic Diseases
Inflammation
Nitric Oxide
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Physiological Effects of Drugs
Arthritis, Rheumatoid
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Free Radical Scavengers
Connective Tissue Diseases

Endothelium-Dependent Relaxing Factors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Anti-Asthmatic Agents
Rheumatic Diseases
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Nitric Oxide
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 10, 2009