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

This study is not yet open for participant recruitment.
Verified October 2012 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: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Tocilizumab
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab

Resource links provided by NLM:

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

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 51
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717859

Contacts
Contact: Veena K Ranganath, M.D. vranganath@mednet.ucla.edu

Locations
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.            
Sponsors and Collaborators
University of California, Los Angeles
Genentech
  More Information

No publications provided

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
Study First Received: October 19, 2012
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013