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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of California, Los Angeles
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Dr. Veena Ranganath, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01717859
First received: October 19, 2012
Last updated: December 16, 2015
Last verified: December 2015

October 19, 2012
December 16, 2015
September 2014
June 2016   (final data collection date for primary outcome measure)
Baseline to month 3 change in total power Doppler synovitis score of 30 joints (range 0-90) [ Time Frame: Baseline, 3 Month ] [ Designated as safety issue: No ]
30 joints will be evaluated.
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.
Complete list of historical versions of study NCT01717859 on ClinicalTrials.gov Archive Site
  • Baseline to month 3 change in total B-mode synovial hypertrophy score of 30 joints (range 0-90) [ Time Frame: Baseline, 3 Month ] [ Designated as safety issue: No ]
    30 joints will be evaluated.
  • Baseline to month 3 change in composite of power Doppler and synovial hypertrophy of 30 joints (range 0-180) [ Time Frame: Baseline, 3 Month ] [ Designated as safety issue: No ]
    30 joints will be evaluated.
  • Baseline to month 3 change in MBDA [ Time Frame: Baseline, 3 Month ] [ Designated as safety issue: No ]
  • Baseline to month 3 change in DAS28ESR [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
    28 joint will be evaluated.
  • Baseline to month 3 change in CDAI [ Time Frame: Baseline, 3 month ] [ Designated as safety issue: No ]
  • 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.
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 or baseline inflammation seen on the ultrasound is a good indicator of how rheumatoid arthritis patients respond to TCZ 4mg/kg and whether early prediction of dose escalation is possible by utilizing ultrasound inflammatory measures.
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.
 
Recruiting
51
December 2016
June 2016   (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   (Adult, Senior)
No
Contact: Veena K Ranganath, M.D. vranganath@mednet.ucla.edu
United States
 
NCT01717859
ML28542, ML28542
No
Not Provided
Not Provided
Dr. Veena Ranganath, University of California, Los Angeles
University of California, Los Angeles
Genentech, Inc.
Principal Investigator: Veena Ranganath, MD, MS UCLA David Geffen School of Medicine, Division of Rheumatology
University of California, Los Angeles
December 2015

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