Last updated: 11/04/2018 10:22:25
A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis
GSK study ID
RA4102651
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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)
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Procedure: Power doppler ultrasonography
Procedure: High frequency ultrasonography
Procedure: Exhaled nitric oxide assessment
Enrollment:
48
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Rheumatoid Arthritis, Osteoarthritis
Product
GW274150
Collaborators
Not applicable
Study date(s)
October 2004 to August 2005
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
- Diagnosis of rheumatoid or osteo-arthritis.
- Weight greater than 45kg (females) or 50kg (males) but not overweight.
- Taking regular doses of glucocorticoid medication (greater than 5mg/day).
- Currently taking biological treatment for RA.
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2005-08-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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