A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00379990
First received: September 21, 2006
Last updated: June 21, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Drug: GW274150 Drug: Prednisolone Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Measurment of synovial vascularity [ Time Frame: Day 1, Day 15 and Day 28 ] [ Designated as safety issue: No ]Power Doppler ultrasonographic measurement of synovial vascularity
Secondary Outcome Measures:
- Synovial thickness [ Time Frame: Day 1, 15 and 28 ] [ Designated as safety issue: No ]High frequency ultrasound measurement of synovial thickness
- Safety: ECG [ Time Frame: Day 1, 15 and 28 ] [ Designated as safety issue: No ]12-lead ECG meaurements
- Safety: Vital Signs [ Time Frame: Day 1, 15 and 28 ] [ Designated as safety issue: No ]Blood pressure and heart rate
- Safety: Laboratory [ Time Frame: Day 1, 8, 15, 22, 28 and Follow Up ] [ Designated as safety issue: No ]Laboratory assessments including liver function tests, amylase and lipase
- Pharmacokinetics: Cmax [ Time Frame: Day 15 and Day 28 ] [ Designated as safety issue: No ]Maximum plasma concentration of GW274150
- Pharmacokinetics: Trough [ Time Frame: Days 8,15 and Day 28 ] [ Designated as safety issue: No ]Trough plasma concentration of GW274150
- Tolerability [ Time Frame: Day 1 to Day 28 and Follow Up ] [ Designated as safety issue: No ]Adverse events
| Enrollment: | 48 |
| Study Start Date: | January 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GW274150 60 mg once daily for 28 days
60 mg GW274150 taken once daily for 28 days
|
Drug: GW274150
60 mg /day
Other Name: GW274150
|
|
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
Other Name: Prednisolone
|
|
Placebo Comparator: Placebo once daily for 28 days
Placebo taken once daily for 28 days
|
Other: Placebo
Placebo
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided by GlaxoSmithKline
Additional 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 |
| Study First Received: | September 21, 2006 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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 Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents |
ClinicalTrials.gov processed this record on May 16, 2013