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

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ClinicalTrials.gov Identifier: NCT01717859
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Dr. Veena Ranganath, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Tocilizumab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab
Study Start Date : September 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab
U.S. FDA Resources

Arm Intervention/treatment
Tocilizumab
All subjects will receive tocilizumab.
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



Primary Outcome Measures :
  1. Baseline to month 3 change in total power Doppler synovitis score of 30 joints (range 0-90) [ Time Frame: Baseline, 3 Month ]
    30 joints will be evaluated.


Secondary Outcome Measures :
  1. Baseline to month 3 change in total B-mode synovial hypertrophy score of 30 joints (range 0-90) [ Time Frame: Baseline, 3 Month ]
    30 joints will be evaluated.

  2. Baseline to month 3 change in composite of power Doppler and synovial hypertrophy of 30 joints (range 0-180) [ Time Frame: Baseline, 3 Month ]
    30 joints will be evaluated.

  3. Baseline to month 3 change in MBDA [ Time Frame: Baseline, 3 Month ]
  4. Baseline to month 3 change in DAS28ESR [ Time Frame: Baseline, 3 month ]
    28 joint will be evaluated.

  5. Baseline to month 3 change in CDAI [ Time Frame: Baseline, 3 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717859


Locations
United States, California
UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Genentech, Inc.
Investigators
Principal Investigator: Veena Ranganath, MD, MS UCLA David Geffen School of Medicine, Division of Rheumatology

Responsible Party: Dr. Veena Ranganath, M.D., M.S., Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01717859     History of Changes
Other Study ID Numbers: ML28542
ML28542 ( Other Identifier: Genentech Inc. )
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017

Keywords provided by Dr. Veena Ranganath, University of California, Los Angeles:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases