A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis - Full Text View

Purpose

This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Prednisolone Drug: SB-681323	Phase II

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:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study

Official Title:	A Randomised, Placebo-Controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Determine dose-response relationship for a a range of doses (7.5 to 25mg) of SB-681323 on levels of a blood protein (CRP)associated with RA. Levels of CRP 72 hours after dosing.

Secondary Outcome Measures:

Explore the relationship between the dose of SB-681323 and the dose of prednisolone that gives the same response in terms of CRP levels.

Estimated Enrollment:	77
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
Must have 3 or more swollen or 3 or more tender/painful joints at screening.
Must be on stable weekly methotrexate (2.5mg â€" 25mg) for at least eight weeks prior to screening.

Exclusion criteria:

Must not be morbidly obese.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134693

Show 24 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MB ChB	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	RA1104046
First Received:	August 24, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00134693
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

SB-681323 rheumatoid arthritis CRP biomarkers

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

Immune System Diseases

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Physiological Effects of Drugs

Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Protective Agents

Neuroprotective Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00134693