A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.

Arthritis, Rheumatoid Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379990
• Other study ID #: RA4104917
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2006
• Last updated: June 21, 2012
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology

• Female subjects who are not capable of becoming pregnant

• Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal finger (MCP) joint with either detectable vascularity or thickness

• Stable doses of disease modifying anti-rheumatic drugs (DMARDs), (which can include but is not restricted to methotrexate, sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrollment

• Patients receiving methotrexate must be on stable folate supplements

• Must have been on stable doses for 2 weeks prior to screening if using COX inhibitors

• Signed consent form

• The patient is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Exclusion criteria:

• The subject is using, or has used, oral glucocorticoids within 8 weeks of enrollment

• The subject is currently receiving anti-rheumatic biological therapy (e.g. infliximab, adalimumab, etanercept or anakinra)

• The subject received their final dose of infliximab or adalimumab within 3 months of enrollment

• The subject received their final dose of etanercept or anakinra within 1 month of enrollment

• The subject has received another investigational drug within 30 days

• The subject drinks more than 28 units (male) or 21 units (female) of alcohol in a week

• History of liver or renal disease in the 6 months prior to screening

• The subject has a history of drug or other allergy

• Subject is positive for Hepatitis B and C or HIV virus

• The subject has positive pregnancy test

• The subject has positive test for drugs of abuse

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• GW274150
60 mg /day
• Prednisolone
7.5 mg/day

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Serbia	GSK Investigational Site	Belgrade
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurment of synovial vascularity	Power Doppler ultrasonographic measurement of synovial vascularity	Day 1, Day 15 and Day 28
Secondary	Synovial thickness	High frequency ultrasound measurement of synovial thickness	Day 1, 15 and 28
Secondary	Safety: ECG	12-lead ECG meaurements	Day 1, 15 and 28
Secondary	Safety: Vital Signs	Blood pressure and heart rate	Day 1, 15 and 28
Secondary	Safety: Laboratory	Laboratory assessments including liver function tests, amylase and lipase	Day 1, 8, 15, 22, 28 and Follow Up
Secondary	Pharmacokinetics: Cmax	Maximum plasma concentration of GW274150	Day 15 and Day 28
Secondary	Pharmacokinetics: Trough	Trough plasma concentration of GW274150	Days 8,15 and Day 28
Secondary	Tolerability	Adverse events	Day 1 to Day 28 and Follow Up