Rheumatoid arthritis
Conditions
Interventions
Product Name: SB-681323 Tablets
Product Code: SB-681323
Pharmaceutical Form: Tablet
Current Sponsor code: SB-681323
Concentration unit:
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is =18 years of age. 2. Patients must use adequate contraception (as defined in protocol) to ensure that no pregnancies occur during the study or for 5 half-lives after the end of the study period. 3. Patient has a body mass index (BMI) of =19 kg/m2 but is not morbidly obese. 4. Patient has a diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology. 5. Patient has serum CRP =15mg/l at screening (maximum 1 week prior to dosing with investigational product). 6. Patient has = 3/66 swollen or = 3/68 tender/painful joints at screening. 7. Patient has urea and creatinine within normal range at screening. 8. The patient must have liver function tests (alanine transaminase, aspartate transaminase and gamma glutamyl transpeptidase) within 1.5 times upper limit of normal (ULN); alkaline phosphatase within 2 times ULN and total bilirubin within normal range at screening. 9. Patient must be on stable oral weekly methotrexate (2.5mg – 25mg) for at least 8 weeks prior to screening. 10. Any additional oral anti-rheumatic therapies (which may include sulphasalazine [= 2g/day] or hydroxychloroquine) must be stable for at least 8 weeks prior to screening. 11. Any additional oral symptomatic relief therapy (which may include NSAIDs or COX-2 inhibitors) must be stable for at least 2 weeks prior to screening. 12. The patient must be capable of giving informed consent and can comply with the study requirements and timetable. 13. Subjects must have a QTc(b) of less than 430msecs for males and 450msecs for females at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant or intend to become pregnant during the study period. 2. The patient has a 3-month prior history of alcohol use > 21 units per week for males and > 14 units per week for females or the patient has a positive alcohol screen at the screening visit (1 unit of alcohol = ½ pint [284mL] of beer, 125ml of wine or 25ml of spirits). 3. The patient has any history of liver disease within 6 months of screening. 4. The patient is infected with Hepatitis B or Hepatitis C within 6 months of screening. 5. The patient has an active infection. 6. The patient has a history of elevated liver function tests on more than one occasion (ALT, AST, ALP or total bilirubin > 1.5 x Upper Limit of Normal [ULN]) in the past 3 months. 7. The patient is receiving a biological anti-rheumatic therapy. 8. The patient is receiving any dose of oral glucocorticoid. 9. The patient has a significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal condition that, in the opinion of the investigator and/or GlaxoSmithKline (GSK) medical monitor, places the patient at an unacceptable risk as a participant in this trial. 10. The patient has participated in a clinical trial within the 3 months prior to the study onset for non-biological therapy; or within 4 months of a biological therapy. 11. The patient has haemoglobin (Hb) 150mmHg or diastolic blood pressure persistently > 90mmHg at screening. 14. The patient has a positive urine drug screen, including ethanol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the single dose response relationship of the dose range of 7.5 to 25 mg of SB-681323 on circulating serum C-Reactive Protein (CRP) levels;Primary end point(s): CRP levels 72 hours post-dose; Secondary Objective: To describe the single dose response relationship of the dose range of 10 to 50 mg of prednisolone on circulating serum CRP levels. To explore the relationship between the dose of SB-681323 and the dose of prednisolone that gives the same response in terms of circulating CRP levels. To describe the single dose response relationship of SB-681323 or prednisolone on circulating serum IL-6 levels. To describe the effect of SB-681323 or prednisolone on circulating biomarker levels | — |
Countries
Germany, United Kingdom
Outcome results
None listed