Last updated: 07/17/2024 17:49:26
A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein that Is an Indicator For Rheumatoid Arthritis
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323
Timeframe: Day 3 (at 72 hour)
Secondary outcomes:
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)
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)
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timeframe: Upto Day 3 (72 hours)
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)
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)
Number of participants with abnormal electrocardiogram (ECG) findings
Timeframe: Day 1 (pre-dose, 1 hour and 3 hour)
Number of participants with clinical chemistry data outside the clinical concern range
Timeframe: Upto Day 3 (pre-dose, 24, 48 and 72 hours
Number of participants with hematology data outside the clinical concern
Timeframe: Upto Day 3 (pre-dose, 24 and 72 hours)
Number of participants with abnormal urinalysis dipstick results
Timeframe: Upto Day 3 (pre-dose, 24 and 72 hours)
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
Interventions:
Drug: Prednisolone
Drug: SB-681323
Enrollment:
77
Observational study model:
Not applicable
Primary completion date:
2006-03-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Arthritis, Rheumatoid
Product
dilmapimod
Collaborators
Not applicable
Study date(s)
June 2005 to August 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 not be morbidly obese.
Inclusion and 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.
Trial location(s)
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Status
Study Complete
Location
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Status
Study Complete
Location
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L9 7AL
Status
Study Complete
Location
GSK Investigational Site
Newcastle, Northumberland, United Kingdom, NE1 4LP
Status
Study Complete
Location
GSK Investigational Site
Shenton Park, Western Australia, Australia, 6008
Status
Study Complete
Location
GSK Investigational Site
Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78054
Status
Study Complete
Location
GSK Investigational Site
Wigan, Lancashire, United Kingdom, WN6 9EP
Status
Study Complete
Location
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Status
Study Complete
Location
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-03-08
Actual study completion date
2006-03-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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