Arthritis, Rheumatoid Clinical Trial
Official title:
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
Verified date | October 2012 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis
Status | Completed |
Enrollment | 51 |
Est. completion date | November 2006 |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bulgaria | GSK Investigational Site | Plovdiv | |
Bulgaria | GSK Investigational Site | Sofia | |
Bulgaria | GSK Investigational Site | Sofia | |
Germany | GSK Investigational Site | Bad Bramstedt | Schleswig-Holstein |
Germany | GSK Investigational Site | Erlangen | Bayern |
Germany | GSK Investigational Site | Hamburg | |
Germany | GSK Investigational Site | Muenchen | Bayern |
Spain | GSK Investigational Site | Madrid | |
Spain | GSK Investigational Site | Santiago de Compostela | |
Spain | GSK Investigational Site | Sevilla | |
Sweden | GSK Investigational Site | Linkoeping | |
Sweden | GSK Investigational Site | Uppsala | |
Ukraine | GSK Investigational Site | Donetsk | |
Ukraine | GSK Investigational Site | Kharkiv | |
Ukraine | GSK Investigational Site | Kiev | |
Ukraine | GSK Investigational Site | Kyiv | |
Ukraine | GSK Investigational Site | Lviv |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Bulgaria, Germany, Spain, Sweden, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C-reactive protein (CRP) levels 72 hours post-dose. | 72 hours post-dose. | ||
Secondary | C-reactive protein (CRP) levels 24 and 48 hours post-dose | 24 and 48 hours post-dose |
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