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The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: rosiglitazone XR (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Disease Activity Score (DAS) following 6 months of treatment

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Kaunas LT-45130, Lithuania

GSK Investigational Site, Vilnius LT-08661, Lithuania

GSK Investigational Site, Glasgow, Lanarkshire G12 0YN, United Kingdom

GSK Investigational Site, Glasgow, Lanarkshire G21 3UW, United Kingdom

GSK Investigational Site, Glasgow, Lanarkshire G31 2ER, United Kingdom

Additional Information

Starting date: November 2004
Last updated: May 31, 2012

Page last updated: August 20, 2015

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