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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: Prednisolone (Drug); SB-681323 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 25mg) for at least eight weeks prior to

screening. Exclusion criteria:

- Must not be morbidly obese.

Locations and Contacts

GSK Investigational Site, Montpellier Cedex 5 34295, France

GSK Investigational Site, Berlin 14109, Germany

GSK Investigational Site, Berlin 13125, Germany

GSK Investigational Site, Berlin 14059, Germany

GSK Investigational Site, Berlin 12163, Germany

GSK Investigational Site, Ekaterinburg 620102, Russian Federation

GSK Investigational Site, Yaroslavl 150003, Russian Federation

GSK Investigational Site, Oxford OX3 7LP, United Kingdom

GSK Investigational Site, Sheffield S10 2RX, United Kingdom

GSK Investigational Site, Villingen-Schwenningen, Baden-Wuerttemberg 78054, Germany

GSK Investigational Site, Cambridge, Cambridgeshire CB2 0QQ, United Kingdom

GSK Investigational Site, Wigan, Lancashire WN6 9EP, United Kingdom

GSK Investigational Site, Liverpool, Merseyside L9 7AL, United Kingdom

GSK Investigational Site, Darlinghurst, New South Wales 2010, Australia

GSK Investigational Site, Hildesheim, Niedersachsen 31134, Germany

GSK Investigational Site, Newcastle, Northumberland NE1 4LP, United Kingdom

GSK Investigational Site, Amiens, Picardie 80054, France

GSK Investigational Site, Douglas, Queensland 4814, Australia

GSK Investigational Site, Woolloongabba, Queensland 4102, Australia

GSK Investigational Site, Chemnitz, Sachsen 09111, Germany

GSK Investigational Site, Leipzig, Sachsen 04107, Germany

GSK Investigational Site, Leipzig, Sachsen 04229, Germany

GSK Investigational Site, Woodville, South Australia 5011, Australia

GSK Investigational Site, Shenton Park, Western Australia 6008, Australia

Additional Information

Starting date: June 2005
Last updated: April 15, 2015

Page last updated: August 23, 2015

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