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Completed

NCT Number: NCT00379990

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Belgrade, Serbia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW274150

Drug

60 mg /day

Prednisolone

Drug

7.5 mg/day

Placebo

Other

Placebo

Primary outcomes

  1. Measurment of synovial vascularity

    Time frame: Day 1, Day 15 and Day 28

    Power Doppler ultrasonographic measurement of synovial vascularity

Secondary outcomes

  1. Synovial thickness

    Time frame: Day 1, 15 and 28

    High frequency ultrasound measurement of synovial thickness

  2. Safety: ECG

    Time frame: Day 1, 15 and 28

    12-lead ECG meaurements

  3. Safety: Vital Signs

    Time frame: Day 1, 15 and 28

    Blood pressure and heart rate

  4. Safety: Laboratory

    Time frame: Day 1, 8, 15, 22, 28 and Follow Up

    Laboratory assessments including liver function tests, amylase and lipase

  5. Pharmacokinetics: Cmax

    Time frame: Day 15 and Day 28

    Maximum plasma concentration of GW274150

  6. Pharmacokinetics: Trough

    Time frame: Days 8,15 and Day 28

    Trough plasma concentration of GW274150

  7. Tolerability

    Time frame: Day 1 to Day 28 and Follow Up

    Adverse events

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 25, 2006
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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