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

NCT00379600 | Completed Phase 2

• 1 other identifier: ARA102198
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 5

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.

Conditions

Arthritis, Rheumatoid

Keywords

Anti-inflammatory treatment; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Disease Activity Score (DAS) following 6 months of treatment

  6 Months

Secondary Outcomes (1)

• 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

Interventions

rosiglitazone XR DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Kaunas, LT-45130, Lithuania

Location

GSK Investigational Site

Vilnius, LT-08661, Lithuania

Location

GSK Investigational Site

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

GSK Investigational Site

Glasgow, Lanarkshire, G21 3UW, United Kingdom

Location

GSK Investigational Site

Glasgow, Lanarkshire, G31 2ER, United Kingdom

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 22, 2006
• Study Start: November 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

LI (2); GB (3)