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A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients


N/A
25 Years
75 Years
Not Enrolling
Both
Arthritis, Rheumatoid

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Trial Information

A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients

Inclusion Criteria


Inclusion criteria:

- Meet the ACR criteria for diagnosis of rheumatoid arthritis.

- Required treatment with Prednisolone.

- Currently on a non-steroidal anti-inflammatory agent (NSAID).

- Willing to stay on current dose of NSAID for two weeks during study.

Exclusion criteria:

- Major health issues such as osteoporosis, diabetes, heart failure, heart attack,
kidney failure, or acute infection.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Modified Disease Activity Score (DAS28), which was composed of swollen and tender joint counts at 28 sites, a patient's global assessment of disease activity using a visual analogue scale (VAS), and ESR.

Outcome Time Frame:

14 days

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

999920/040

NCT ID:

NCT00330889

Start Date:

February 2004

Completion Date:

December 2006

Related Keywords:

  • Arthritis, Rheumatoid
  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteBirmingham, Alabama  35209
GSK Investigational SiteOmaha, Nebraska  68131