Arthritis, Rheumatoid
Conditions
Keywords
Anti-inflammatory treatment, Rheumatoid Arthritis
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 (DMARD) treatment does not give adequate relief.
Interventions
DRUGrosiglitazone XR
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Activity Score (DAS) following 6 months of treatment | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Disease activity at 3 months and 6 months, e.g., number of affected joints Patient Assessments of Improvements in Disease Activity, e.g., fatigue and pain assessment Assessment of safety, tolerability and biological activity | Disease activity at 3 months and 6 months |
Countries
Lithuania, United Kingdom
Outcome results
None listed