Status:
COMPLETED
The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To assess whether the anti-inflammatory effects of rosiglitazone result in improvements in Rheumatoid Arthritis symptoms in patients for whom their existing Disease Modifying Anti-Rheumatic Drug (DMAR...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Rheumatoid Arthritis insufficiently controlled by existing disease-modifying anti-rheumatic drugs
- Subjects will have at least 6 swollen joints plus 2 of the following: 6 tender joints (of 28 joints); early morning stiffness lasting more than 30 minutes; ESR greater or equal to 28mm/h
- must be receiving a stable dose of disease-modifying anti-rheumatic therapy for at least 2 months prior to participating in the study.
- Exclusion criteria:
- Women who are lactating, pregnant, or planning to become pregnant during the course of the study including 30 days following conclusion of study medication
- Systolic blood pressure (SBP) \>165 mmHg or diastolic blood pressure (DBP) \>95 mmHg while receiving optimal antihypertensive therapy
- Any clinically significant abnormality identified on the screening physical exam, laboratory tests, or ECG, which in the judgement of the Investigator makes the subject unsuitable for inclusion in the study
- a history of alcohol abuse within the past 3 years or consumes \>3 units per day for males and \>2 units per day for females or has a history of cirrhosis or stigmata of chronic liver disease
- a history of liver disease or has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2.5 times upper limit of normal and total bilirubin levels greater than 1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin or Gilbert's syndrome) at screening
- using glucocorticoid at doses \>10 mg/day currently or within the last 3 months or may be expected to do so during the course of the study
- The subject's dose of NSAIDs, COX-2 inhibitors or glucocorticoids has changed at any time during the past 2 weeks prior to screening or may be expected to change during the course of the study
- The subject's dose or treatment with a statin has changed at any time during the past 3 months prior to screening or may be expected to change during the course of the study
- a history of renal disease or has serum creatinine = 132mol/L for males and =130mol for females
- has diabetes mellitus that requires medication or hyperglycaemia with a HbA1c of \>7%
- History of new cardiovascular event within the last 6 months (i.e., intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome \[non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia; or major intervention (e.g., cardiac surgery or angiography plus stenting) scheduled
- Concurrent or past medical history of congestive heart failure or pulmonary oedema
- A presence of severe peripheral oedema or a medically serious fluid-related event
- has significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or immunological conditions that, in the opinion of the Investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial
- a history of malignancy in the last 5 years, except for surgically cured basal cell carcinoma (\>2 years prior to first dosing)
- a history of HIV, or chronic hepatitis B or positive C serology
- a history of drug abuse
- has participated in a clinical trial within the 3 months before the start of the study for non-biological therapy; or within 6 months of a biological therapy
- on a biological therapy or has received biological therapy within 6 months prior to screening
- has donated blood in excess of 500 mL within 56 days prior to dosing
- The subject is at risk of non-compliance in following directions or adhering to study restrictions
- a history of drug or other allergy, which, in the opinion of the physician responsible, contraindicates their participation
- has anaemia defined by haemoglobin concentration \<11 g/dL for males or \<10 g/dL for females
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00379600
Start Date
November 1 2004
End Date
December 1 2006
Last Update
October 26 2016
Active Locations (5)
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1
GSK Investigational Site
Kaunas, Lithuania, LT-45130
2
GSK Investigational Site
Vilnius, Lithuania, LT-08661
3
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G12 0YN
4
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G21 3UW