NCT00242853

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
Last Updated

October 13, 2008

Status Verified

October 1, 2008

First QC Date

October 19, 2005

Last Update Submit

October 9, 2008

Conditions

Keywords

iNOSRheumatoid arthritisExhaled NO

Interventions

Also known as: Exhaled nitric oxide assessment, Power doppler ultrasonography

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Taking regular doses of glucocorticoid medication (greater than 5mg/day).
  • Currently taking biological treatment for RA.
  • Recent participation in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

London, W6 8LH, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 21, 2005

Study Start

October 1, 2004

Last Updated

October 13, 2008

Record last verified: 2008-10

Locations