Effects Of Prednisolone On Rheumatoid Arthritis Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00330889

Enrollment

Registered

2006-05-29

Start date

2004-02-29

Completion date

2006-12-31

Last updated

2012-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis

Brief summary

This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of Prednisolone on Rheumatoid Arthritis (RA) patients.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	14 days
The levels of selected markers of inflammation, which could include (but were not limited to) ESR, C-reactive protein (CRP), interleukin-6 (IL-6), Rheumatoid factor (RF), and soluble tumor necrosis factor-receptor (TNF-R)	14 days

Countries

Canada, United Kingdom, United States

Outcome results