Effects Of Prednisolone On Rheumatoid Arthritis Patients - Full Text View

Effects Of Prednisolone On Rheumatoid Arthritis Patients

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00330889

Purpose

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

Condition	Phase
Rheumatoid Arthritis	Phase I

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Defined Population, Prospective Study

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

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	45
Study Start Date:	February 2004

Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330889

Locations


United States, California
	GSK Clinical Trials Call Center
	Los Angeles, California, United States, 90095

United States, Florida
	GSK Clinical Trials Call Center
	Daytona Beach, Florida, United States, 32114

United States, Nebraska
	GSK Clinical Trials Call Center
	Omaha, Nebraska, United States, 68198

United States, Pennsylvania
	GSK Clinical Trials Call Center
	Philadelphia, Pennsylvania, United States, 19104

Canada, Manitoba
	GSK Clinical Trials Call Center
	Winnipeg, Manitoba, Canada, R3A-1M4

United Kingdom
	GSK Clinical Trials Call Center
	Sheffield, United Kingdom, S10 2RX

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	999920/040
First Received:	May 26, 2006
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00330889
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

Rheumatoid Arthritis

Study placed in the following topic categories:

Autoimmune Diseases

Musculoskeletal Diseases

Methylprednisolone

Joint Diseases

Arthritis

Prednisolone

Connective Tissue Diseases

Arthritis, Rheumatoid

Methylprednisolone acetate

Prednisolone acetate

Rheumatic Diseases

Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Glucocorticoids

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008