A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship
- Conditions
- Rheumatoid arthritis
- Registration Number
- EUCTR2004-005115-29-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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) < 9 and platelet count < 150000/mm3
12. Hypersensitivity to prednisolone tablet or ingredients
13. The patient has a resting systolic blood pressure persistently > 150mmHg or diastolic blood pressure persistently > 90mmHg at screening.
14. The patient has a positive urine drug screen, including ethanol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method