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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 23, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: Tocilizumab
Phase 4

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Baseline or 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:
  • Baseline or 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.

  • Baseline or 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: September 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Veena K Ranganath, M.D.         
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
  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: September 23, 2014
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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014