Last updated: 11/04/2018 10:22:48
A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects.
Trial description: This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Power Doppler ultrasonographic measurement of synovial vascularity: Total Vascularity Score
Timeframe: Up to Day 28
Secondary outcomes:
Power Doppler ultrasonographic measurement of synovial vascularity: Power Doppler Area (PDA).
Timeframe: Up to Day 28
High frequency ultrasound measurement of synovial thickness: Total Thickness Score.
Timeframe: Up to Day 28
Maximum plasma concentration (Cmax) and Trough plasma concentration of GW274150
Timeframe: Pre-dose, 0.5 hour, 1 hour and 2 hours post-dose on Day 15 and 28 for Cmax and Day 8, 15 and 28 for Trough
Mean Haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell Count
Timeframe: Up to Day 28
Mean Hematology parameters: Reticulocytes, Red Blood Cell Count (RBC)
Timeframe: Up to Day 28
Mean Hematology parameters: Hematocrit
Timeframe: Up to Day 28
Mean Hematology parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)
Timeframe: Up to Day 28
Mean Hematology parameters: erythrocyte sedimentation rate
Timeframe: Up to Day 28
Hematology parameters: mean corpuscle hemoglobin
Timeframe: Up to Day 28
Hematology parameters: mean corpuscle volume
Timeframe: Up to Day 28
Laboratory parameters: total protein, albumin
Timeframe: Up to Day 28
laboratory parameters: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), creatine kinase, lactate dehydrogenase
Timeframe: Up to Day 28
laboratory parameters: lipase, amylase
Timeframe: Up to Day 28
Laboratory parameters: direct bilirubin, creatinine, uric acid
Timeframe: Up to Day 28
Laboratory parameters: C-reactive protein
Timeframe: Up to Day 28
Laboratory parameters: calcium, cholesterol, chloride, glucose, bicarbonate, potassium, magnesium, sodium, phosphate, triglycerides, urea
Timeframe: Up to Day 28
Number of participants with incidence of adverse events (AE) and adverse events leading to discontinuation of study drug
Timeframe: Up to Day 28
Number of participants with Serious adverse Events (SAEs) and deaths
Timeframe: Up to Day 28
Number of participants with abnormal electrocardiogram (ECG) findings
Timeframe: Up to Day 28
Mean systolic and diastolic blood pressure (SBP and DBP)
Timeframe: Up to Day 28
Mean heart rate
Timeframe: Up to Day 28
summary of Change from Baseline of Interleukin-6
Timeframe: Baseline (pre-dose Day 1) and up to Day 28
Interventions:
Drug: GW274150
Drug: Prednisolone
Other: Placebo
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2007-19-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Arthritis, Rheumatoid
Product
GW274150
Collaborators
Not applicable
Study date(s)
January 2006 to December 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology
- Female subjects who are not capable of becoming pregnant
- The subject is using, or has used, oral glucocorticoids within 8 weeks of enrollment
- The subject is currently receiving anti-rheumatic biological therapy (e.g. infliximab, adalimumab, etanercept or anakinra)
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology
- Female subjects who are not capable of becoming pregnant
- Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal finger (MCP) joint with either detectable vascularity or thickness
- Stable doses of disease modifying anti-rheumatic drugs (DMARDs), (which can include but is not restricted to methotrexate, sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrollment
- Patients receiving methotrexate must be on stable folate supplements
- Must have been on stable doses for 2 weeks prior to screening if using COX inhibitors
- Signed consent form
- The patient is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Exclusion criteria:
- The subject is using, or has used, oral glucocorticoids within 8 weeks of enrollment
- The subject is currently receiving anti-rheumatic biological therapy (e.g. infliximab, adalimumab, etanercept or anakinra)
- The subject received their final dose of infliximab or adalimumab within 3 months of enrollment
- The subject received their final dose of etanercept or anakinra within 1 month of enrollment
- The subject has received another investigational drug within 30 days
- The subject drinks more than 28 units (male) or 21 units (female) of alcohol in a week
- History of liver or renal disease in the 6 months prior to screening
- The subject has a history of drug or other allergy
- Subject is positive for Hepatitis B and C or HIV virus
- The subject has positive pregnancy test
- The subject has positive test for drugs of abuse
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
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
2007-19-12
Actual study completion date
2007-19-12
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.
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