Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab (RASTS)

This study is not yet open for participant recruitment.
Verified July 2013 by University of California, Los Angeles
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Dr. Veena Ranganath, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01717859
First received: October 19, 2012
Last updated: July 3, 2013
Last verified: July 2013

October 19, 2012
July 3, 2013
January 2013
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01717859 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab
Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Rheumatoid Arthritis
Drug: 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
Tocilizumab
All subjects will receive tocilizumab.
Intervention: Drug: Tocilizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
51
December 2014
December 2014   (final data collection date for primary outcome measure)
  1. Patient must meet 1987 ACR criteria,
  2. Age > 18 years of age,
  3. Baseline DAS28/ESR>4.4,
  4. Stable concomitant DMARDs,
  5. Stable prednisone <10mg or equivalent, and
  6. Power Doppler score of >=10
Both
18 Years and older
No
Contact: Veena K Ranganath, M.D. vranganath@mednet.ucla.edu
United States
 
NCT01717859
ML28542, ML28542
No
Dr. Veena Ranganath, University of California, Los Angeles
University of California, Los Angeles
Genentech
Principal Investigator: Veena Ranganath, MD, MS UCLA David Geffen School of Medicine, Division of Rheumatology
University of California, Los Angeles
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP