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

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ClinicalTrials.gov Identifier: NCT00379990
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: GW274150 Drug: Prednisolone Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007


Arm Intervention/treatment
Experimental: GW274150 60 mg once daily for 28 days
60 mg GW274150 taken once daily for 28 days
Drug: GW274150
60 mg /day

Active Comparator: Prednisolone 7.5 mg once daily for 28 days
7.5 mg prednisolone taken once daily for 28 days
Drug: Prednisolone
7.5 mg/day

Placebo Comparator: Placebo once daily for 28 days
Placebo taken once daily for 28 days
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Measurment of synovial vascularity [ Time Frame: Day 1, Day 15 and Day 28 ]
    Power Doppler ultrasonographic measurement of synovial vascularity


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379990


Locations
Serbia
GSK Investigational Site
Belgrade, Serbia, 11000
United Kingdom
GSK Investigational Site
London, United Kingdom, W6 8LH
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00379990     History of Changes
Other Study ID Numbers: RA4104917
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by GlaxoSmithKline:
iNOS
Exhaled NO
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents