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A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

NCT ID: NCT00242853

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Rheumatoid Arthritis Osteoarthritis

Keywords

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iNOS Rheumatoid arthritis Exhaled NO

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Power doppler ultrasonography

Intervention Type PROCEDURE

High frequency ultrasonography

Intervention Type PROCEDURE

Exhaled nitric oxide assessment

Intervention Type PROCEDURE

Other Intervention Names

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Exhaled nitric oxide assessment Power doppler ultrasonography

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RA4102651

Identifier Type: -

Identifier Source: org_study_id