Status:
COMPLETED
Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This is a study of GW274150, an iNOS (inducible nitric oxide synthase) inhibitor to investigate safety, tolerability and pharmacokinetics (PK) in the rheumatoid arthritis (RA) population (greater than...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- No clinically significant disease as determined by history, physical examination and screening investigations.
- RA subjects on methotrexate (7.5mg - 25mg per week)
- Body weight \>50 kg for males and \>45 kg for females, who are not morbidly obese
- Diagnosis of RA
- Active disease defined as DAS28 = 4.0 and at least one MCP joint with either detectable vascularity or thickness
- Stable doses of DMARDs (Disease-modifying anti-rheumatic drugs, which must include methotrexate and can also include but is not restricted to sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrolment
- Must be on stable folate supplements
- Subjects using NSAIDs or Cox-2 inhibitors must have been on stable doses for 2 weeks prior to screening
- LFT functions (ALT, AST, ALP) = 1.5 x ULN at screening and which have been stable on at least 2 occasions in the 7 months prior to screening
- Must provide signed and dated written informed consent prior to admission to the study
- Ability to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Exclusion criteria:
- Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- Clinically significant abnormalities in safety laboratory analysis at screening
- Pregnant or nursing women
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined
- As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the subject unfit for the study
- Taking \>10mg/day oral glucocorticoids
- Currently receiving anti-rheumatic biological therapy
- Received their final dose of infliximab or adalimumab within 3 months of enrollment
- Received their final dose of etanercept or anakinra within 1 month of enrollment
- Has received an investigational drug or participated in any other NCE research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to enrol.ment
- Regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female.
- Has a screening QTc value of \>430msec (males) or \>450msec (females), PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements
- History of liver or renal disease in the 6 months prior to screening
- Current renal insufficiency (subject must have an estimated creatinine clearance less than50mL/min as estimated from the serum creatinine using the Cockroft-Gault formula
- Has donated a unit of blood within the previous month or intends to donate in the month after completing the study
- Has a history or drug or other allergy, which in the opinion of the physician responsible, contraindicates their participation
- History of, or risk factors for, HIV, Hepatitis B and Hepatitis C
- History of drug abuse
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00370435
Start Date
August 1 2005
End Date
September 1 2005
Last Update
May 30 2017
Active Locations (1)
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1
GSK Investigational Site
London, United Kingdom, W6 8LH