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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00379600
First received: September 21, 2006
Last updated: May 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: rosiglitazone XR
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Disease Activity Score (DAS) following 6 months of treatment [ Time Frame: 6 Months ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Disease activity at 3 months and 6 months ]

Enrollment: 96
Study Start Date: November 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rosiglitazone XR
    Other Name: rosiglitazone XR
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379600

Locations
Lithuania
GSK Investigational Site
Kaunas, Lithuania, LT-45130
GSK Investigational Site
Vilnius, Lithuania, LT-08661
United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G12 0YN
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G21 3UW
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G31 2ER
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00379600     History of Changes
Other Study ID Numbers: ARA102198
Study First Received: September 21, 2006
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by GlaxoSmithKline:
Anti-inflammatory treatment
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Rosiglitazone
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014