Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)

NCT ID: NCT00256919

Last Updated: 2012-11-05

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-11-30

Brief Summary

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This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis

Detailed Description

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Conditions

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Arthritis, Rheumatoid

Keywords

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GW856553 biomarkers CRP rheumatoid arthritis

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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GW856553

Intervention Type DRUG

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

Plovdiv, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Erlangen, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Bad Bramstedt, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Santiago de Compostela, , Spain

Site Status

GSK Investigational Site

Seville, , Spain

Site Status

GSK Investigational Site

Linköping, , Sweden

Site Status

GSK Investigational Site

Uppsala, , Sweden

Site Status

GSK Investigational Site

Donetsk, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kiev, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Lviv, , Ukraine

Site Status

Countries

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Bulgaria Germany Spain Sweden Ukraine

References

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Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.

Reference Type DERIVED
PMID: 23254770 (View on PubMed)

Other Identifiers

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RA3103730

Identifier Type: -

Identifier Source: org_study_id