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Completed

NCT Number: NCT00330889

Effects Of Prednisolone On Rheumatoid Arthritis Patients

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

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 14 days

  2. 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)

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
May 29, 2006
Registry last updated
Oct 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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