Clinical trial NCT00134693: A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis
Official title: A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: SB-681323 rheumatoid arthritis CRP biomarkers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323
timeFrame: Day 3 (at 72 hour)
Secondary outcomes:
measure: Analysis of CRP levels 24 and 48 hours post-dose following SB-681323
timeFrame: Day 1 (at 24 hour) and Day 2 (at 48 hour)
measure: Analysis of Interleukin (IL)-6 levels up to 72 hours post-dose following SB-681323
timeFrame: Upto Day 3 (at 1, 3, 24 and 72 hour)
measure: Number of participants with adverse events (AE) and serious adverse events (SAE)
timeFrame: Upto Day 3 (72 hours)
measure: Change from Baseline in vital sign systolic blood pressure (SBP) and diastolic blood pressure (DBP)
timeFrame: Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)
measure: Change from Baseline in vital sign heart rate
timeFrame: Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)
measure: Number of participants with abnormal electrocardiogram (ECG) findings
timeFrame: Day 1 (pre-dose, 1 hour and 3 hour)
measure: Number of participants with clinical chemistry data outside the clinical concern range
timeFrame: Upto Day 3 (pre-dose, 24, 48 and 72 hours
measure: Number of participants with hematology data outside the clinical concern
timeFrame: Upto Day 3 (pre-dose, 24 and 72 hours)
measure: Number of participants with abnormal urinalysis dipstick results
timeFrame: Upto Day 3 (pre-dose, 24 and 72 hours)
measure: Whole blood messenger RNA (mRNA) levels of tumor necrosis factor alpha [TNF-α], IL-8, IL-1β and Cyclo-oxygenase-2 [COX-2] (and other genes implicated in the pathogenesis of RA or genes involved in the mode of action of the compounds administered)
timeFrame: Pre-dose, 45 minutes, 90 minutes and 3 hours on Day 1
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Douglas
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Woolloongabba
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Daw Park
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Woodville
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Hobart
country: Australia
facility: GSK Investigational Site
state: Tasmania
city: Shenton Park
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Amiens
country: France
facility: GSK Investigational Site
state: Picardie
city: Montpellier Cedex 5
country: France
facility: GSK Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Hildesheim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Wigan
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Newcastle
country: United Kingdom
facility: GSK Investigational Site
state: Northumberland
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: