Last updated: 11/04/2018 04:42:36
The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change in disease activity score (DAS) based on a 28-joint count (DAS28) after 6 months of treatment
Timeframe: Baseline (Day 1) and Month 6
Secondary outcomes:
Changes in tender/painful joint count (TJC) and swollen joint count (SJC) at 3 and 6 months
Timeframe: Up to 6 months
Number of participants with American College of Rheumatology-defined (ACR-defined) improvements of 20%, 50% and 70% in a core set of secondary rheumatological endpoints: ACR20, ACR50 and ACR70 response at 3 and 6 months
Timeframe: Up to 6 months
Change from baseline in DAS28 at 3 months
Timeframe: Baseline (Day 1) and 3 months
Change from baseline in Participant’s and physician’s global assessment (GA) of disease activity at month 3 and 6
Timeframe: Baseline (Day 1) and Month 3, Month 6
Number of participants with Health assessment questionnaire (HAQ) by visit-Day 1, Month 3 and month 6
Timeframe: Day 1, Month 3 and Month 6
Number of participants with HAQ by Visit - aids or devices associated with dressing and grooming, arising, eating, walking, hygiene, reach, grip and activities
Timeframe: Up to month 6
Number of participants with HAQ by Visit - Help from Another Person
Timeframe: Up to 6 months
Change from baseline for Functional Disability Index (FDI) at Months 3 and 6
Timeframe: Baseline (Day 1 pre-dose) and Month 3 and Month 6
Change from baseline for Fatigue Symptom Inventory (FSI) at month 6
Timeframe: Baseline (Day 1) and month 6
Change from baseline assessment of Pain by visual analog scale
Timeframe: Baseline (Day 1), Month 3 and Month 6
Change from baseline Markers of insulin resistance: fasting glucose
Timeframe: Baseline (Day 1) and month 6
Change from baseline Markers of insulin resistance: fasting insulin
Timeframe: Baseline (Day 1) and month 6
Change from baseline Markers of insulin resistance: C-peptide
Timeframe: Baseline (Day 1) and month 6
Change from baseline Markers of insulin resistance: Glycosylated Haemoglobin (HbA1C)
Timeframe: Baseline (Day 1) and month 6
Markers of inflammation: Ratio to Baseline C-Reactive Protein (CRP)
Timeframe: Baseline (Day 1) and month 6
Markers of inflammation: Ratio to baseline high sensitivity C-reactive protein (hsCRP) at month 6
Timeframe: Baseline (Day 1) and month 6
Markers of inflammation: Ratio to baseline of erythrocyte sedimentation rate
Timeframe: Baseline (Day 1), 1 month, 3 month and 6 months
Lipids: high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol and triglycerides ratio to baseline at month 6
Timeframe: Baseline (Day 1) and month 6
Change from baseline -Systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timeframe: Baseline (Day 1) and month 1, month 3 and month 6
Vital signs_Change from baseline-heart rate
Timeframe: Baseline (Day 1), 1 month, 3 month and 6 months
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 7 months
Change from baseline-Haematology: basophils, eosinophils, lymphocytes, monocytes, WBC count, platelet count, total neutrophils
Timeframe: Baseline (Day 1), 1 month, 3 month and 6 months
Haematology: Change from baseline- Hemoglobin, Mean cell hemoglobin concentration (MCHC)
Timeframe: Baseline (Day 1), 1 month, 3 month and 6 months
Change from baseline-Haematology: Hematocrit
Timeframe: Baseline (Day 1), 1 month, 3 month and 6 months
Haematology: Change from baseline-Mean cell hemoglobin (MCH)
Timeframe: Baseline (Day 1) and Month 1, Month 3 and Month 6
Change from baseline-Haematology: Mean Cell Volume (MCV)
Timeframe: Baseline (Day 1) and Month 1, Month 3 and Month 6
Haematology: Change from baseline- Red blood cell (RBC) count
Timeframe: Baseline (Day 1) and Month 1, Month 3 and Month 6
Clinical chemistry: Change from baseline- alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatine phosphokinase (CPK), Gamma glutamyl transferase (GGT)
Timeframe: Baseline (Day 1), 1 month, 3 month, 5 month and 6 months
Clinical chemistry: Change from baseline- Albumin, total protein
Timeframe: Baseline (Day 1) and month 1, month 3, month 5, month 6
Change from baseline- direct, indirect bilirubin, total bilirubin, Creatinine
Timeframe: Baseline (Day 1), 1 month, 3 month, 5 months and 6 months
Clinical chemistry: Change from baseline-Cholesterol, glucose, potassium, sodium, urea
Timeframe: Baseline (Day 1) and Month 1, Month 3 and Month 6
Interventions:
Enrollment:
98
Primary completion date:
2006-08-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Arthritis, Rheumatoid
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
November 2004 to December 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion Criteria:
- Rheumatoid Arthritis insufficiently controlled by existing disease-modifying anti-rheumatic drugs
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Trial location(s)
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G31 2ER
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G21 3UW
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Status
Study Complete
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
Study complete
Actual primary completion date
2006-08-12
Actual study completion date
2006-08-12
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.
Additional information about the trial
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