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

A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00256919

Enrollment

Registered

2005-11-22

Start date

2005-11-30

Completion date

2006-11-30

Last updated

2012-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

GW856553, biomarkers, CRP, rheumatoid arthritis

Brief summary

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

Interventions

DRUGGW856553

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
C-reactive protein (CRP) levels 72 hours post-dose.	72 hours post-dose.

Secondary

Measure	Time frame
C-reactive protein (CRP) levels 24 and 48 hours post-dose	24 and 48 hours post-dose

Countries

Bulgaria, Germany, Spain, Sweden, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026