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NCT00242853 Clinical Trial

A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00242853
Other study ID # RA4102651
Secondary ID
Status Completed
Phase N/A
First received October 19, 2005
Last updated October 9, 2008
Start date October 2004

Study information
Verified date October 2008
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Power doppler ultrasonography

• High frequency ultrasonography

• Exhaled nitric oxide assessment

Locations
Country Name City State
United Kingdom GSK Investigational Site London

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

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