Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab (RASTS)
The purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how patients' rheumatoid arthritis is responding to the TCZ and whether patients should be dose escalated earlier from 4 mg/kg to 8mg/kg.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab|
- Change in total power Doppler synovitis score of 28 joints (range 0-42) [ Time Frame: Baseline, 1 Month ] [ Designated as safety issue: No ]28 joints will be evaluated.
- Change in total B-mode synovial hypertrophy score of 28 joints (range 0-42) [ Time Frame: Baseline, 1 Month ] [ Designated as safety issue: No ]28 joints will be evaluated.
- Change in composite of power Doppler + synovial hypertrophy of 28 joints (range 0-84) [ Time Frame: Baseline, 1 Month ] [ Designated as safety issue: No ]28 joints will be evaluated.
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
All subjects will receive tocilizumab.
All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg.
Other Name: Actemra
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717859
|Contact: Veena K Ranganath, M.D.||firstname.lastname@example.org|
|United States, California|
|UCLA David Geffen School of Medicine, Division of Rheumatology||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Principal Investigator: Veena K Ranganath, M.D.|
|Principal Investigator:||Veena Ranganath, MD, MS||UCLA David Geffen School of Medicine, Division of Rheumatology|