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

NCT ID: NCT00134693

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-21

Study Completion Date

2006-08-03

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Prednisolone

Intervention Type DRUG

SB-681323

Intervention Type DRUG

Other Intervention Names

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Prednisolone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Darlinghurst, New South Wales, Australia

Site Status

GSK Investigational Site

Douglas, Queensland, Australia

Site Status

GSK Investigational Site

Woolloongabba, Queensland, Australia

Site Status

GSK Investigational Site

Daw Park, South Australia, Australia

Site Status

GSK Investigational Site

Woodville, South Australia, Australia

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GSK Investigational Site

Hobart, Tasmania, Australia

Site Status

GSK Investigational Site

Shenton Park, Western Australia, Australia

Site Status

GSK Investigational Site

Amiens, Picardie, France

Site Status

GSK Investigational Site

Montpellier, , France

Site Status

GSK Investigational Site

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Hildesheim, Lower Saxony, Germany

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GSK Investigational Site

Chemnitz, Saxony, Germany

Site Status

GSK Investigational Site

Leipzig, Saxony, Germany

Site Status

GSK Investigational Site

Leipzig, Saxony, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Moscow, , Russia

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GSK Investigational Site

Ryazan, , Russia

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GSK Investigational Site

Yaroslavl, , Russia

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GSK Investigational Site

Yekaterinburg, , Russia

Site Status

GSK Investigational Site

Cambridge, Cambridgeshire, United Kingdom

Site Status

GSK Investigational Site

Wigan, Lancashire, United Kingdom

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GSK Investigational Site

Liverpool, Merseyside, United Kingdom

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GSK Investigational Site

Newcastle, Northumberland, United Kingdom

Site Status

GSK Investigational Site

Oxford, , United Kingdom

Site Status

GSK Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

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Australia France Germany Russia United Kingdom

Other Identifiers

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RA1104046

Identifier Type: -

Identifier Source: org_study_id

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