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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00393146 |
This study is designed to look at the safety, tolerability and effectiveness of 28 days of dosing of GW856553 in rheumatoid arthritis patients.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: GW856553 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled Study to Investigate the Safety and Tolerability and Clinical Activity of 28 Days of Oral Repeat Dosing With GW856553 at 7.5mg BID in Subjects With Active Rheumatoid Arthritis on Stable Anti-Rheumatic Therapy. |
Estimated Enrollment: | 54 |
Study Start Date: | October 2006 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
To be eligible, female subjects must have a negative pregnancy test (i.e. serum beta hCG test) and be of:
Exclusion criteria:
administered therapies with long half-lives e.g. infliximab) or 3 months (for subcutaneously administered therapies or iv administered therapies with short halflives e.g. adalimumab or etanercept) prior to randomisation.
Romania | |
GSK Investigational Site | |
Bucharest, Romania, 20983 | |
GSK Investigational Site | |
Bucharest, Romania, 11172 | |
Russian Federation | |
GSK Investigational Site | |
Moscow, Russian Federation, 115522 | |
GSK Investigational Site | |
St Pertersburg, Russian Federation, 196247 | |
GSK Investigational Site | |
Moscow, Russian Federation, 630117 | |
GSK Investigational Site | |
Moscow, Russian Federation, 109240 | |
GSK Investigational Site | |
Yaroslavl, Russian Federation, 150003 | |
Spain | |
GSK Investigational Site | |
La Coruña, Spain, 15006 | |
GSK Investigational Site | |
Madrid, Spain, 28034 | |
GSK Investigational Site | |
Madrid, Spain, 28007 | |
GSK Investigational Site | |
Santiago de Compostela, Spain, 15706 | |
GSK Investigational Site | |
Madrid, Spain, 28035 | |
GSK Investigational Site | |
Madrid, Spain, 28046 |
Study Director: | GSK Clinical Trials, MD, MPH, FFPM | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | RA3103718 |
Study First Received: | October 24, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00393146 |
Health Authority: | Spain: Drugs and Health Products Agency; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health |
Rheumatoid arthritis MRI |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |