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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00256919
• Date of registration: 21/11/2005
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
• Scientific 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
• Date of first enrolment: November 2005
• Target sample size: 51
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00256919
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Bulgaria, Germany, Spain, Sweden, Ukraine

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: GW856553

Primary Outcome(s)

C-reactive protein (CRP) levels 72 hours post-dose. [Time Frame: 72 hours post-dose.]

Secondary Outcome(s)

C-reactive protein (CRP) levels 24 and 48 hours post-dose [Time Frame: 24 and 48 hours post-dose]

Secondary ID(s)

RA3103730

Source(s) of Monetary Support

Please refer to primary and secondary sponsors