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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW274150 60 mg once daily for 28 days | Experimental | 60 mg GW274150 taken once daily for 28 days |
|
| Prednisolone 7.5 mg once daily for 28 days | Active Comparator | 7.5 mg prednisolone taken once daily for 28 days |
|
| Placebo once daily for 28 days | Placebo Comparator | Placebo taken once daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW274150 | Drug | 60 mg /day |
| |
| Prednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| Measurment of synovial vascularity | Power Doppler ultrasonographic measurement of synovial vascularity | Day 1, Day 15 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Synovial thickness | High frequency ultrasound measurement of synovial thickness | Day 1, 15 and 28 |
| Safety: ECG | 12-lead ECG meaurements |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Belgrade | 11000 | Serbia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22409880 | Derived | Seymour M, Petavy F, Chiesa F, Perry H, Lukey PT, Binks M, Donatien PD, Freidin AJ, Eckersley RJ, McClinton C, Heath K, Prodanovic S, Radunovic G, Pilipovic N, Damjanov N, Taylor PC. Ultrasonographic measures of synovitis in an early phase clinical trial: a double-blind, randomised, placebo and comparator controlled phase IIa trial of GW274150 (a selective inducible nitric oxide synthase inhibitor) in rheumatoid arthritis. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):254-61. Epub 2012 Apr 13. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2017 | |
| Reset | Feb 9, 2018 | |
| Release | Mar 6, 2018 | |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2017 | Feb 9, 2018 | |||
| Mar 6, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C409004 | GW 274150 |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
7.5 mg/day |
|
| Placebo | Other | Placebo |
|
| Day 1, 15 and 28 |
| Safety: Vital Signs | Blood pressure and heart rate | Day 1, 15 and 28 |
| Safety: Laboratory | Laboratory assessments including liver function tests, amylase and lipase | Day 1, 8, 15, 22, 28 and Follow Up |
| Pharmacokinetics: Cmax | Maximum plasma concentration of GW274150 | Day 15 and Day 28 |
| Pharmacokinetics: Trough | Trough plasma concentration of GW274150 | Days 8,15 and Day 28 |
| Tolerability | Adverse events | Day 1 to Day 28 and Follow Up |
| London |
| W6 8LH |
| United Kingdom |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |