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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00674635 |
This is a randomized, double-blinded, placebo-controlled adaptive, dose finding study to investigate the safety, tolerability, PK, PD and efficacy of single and repeat intravenous infusions of GSK315243A in patients with active rheumatoid arthritis. The study is divided into 2 parts: Part A is an adaptive, dose finding phase which will provide safety, tolerability, PK and PD on single intravenous infusions. Part B is a repeat dose phase which will provide safety, tolerability, PK, PD and efficacy following repeat intravenous infusions of a selected dose level.
Condition | Intervention | Phase |
Rheumatoid Arthritis |
Drug: GSK3152314A |
Phase II |
MedlinePlus related topics: | Rheumatoid Arthritis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Bayesian Adaptive Dose Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Intravenous Infusions GSK315234A in Patients With Active Rheumatoid Arthritis (RA) |
Estimated Enrollment: | 112 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Show 30 Study Locations |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104972 |
First Received: | April 22, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00674635 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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