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Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: February 12, 2009
Last updated: May 29, 2015
Last verified: May 2015
The purpose of this investigation is to determine the effects of Rituxan therapy in individuals with rheumatoid arthritis on endothelial function and other markers of endothelial function

Condition Intervention
Endothelial Function
Rheumatoid Arthritis
Drug: Rituxan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Flow-mediated Vasodilation (FMD) [ Time Frame: 12 weeks, 24 weeks ]
    endothelial function as assessed by flow-mediated vasodilation of the brachial artery

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituxan Drug: Rituxan
1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study


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

Inclusion Criteria:

  • Able and willing to give written informed consent and comply with the requirements of the study protocol
  • Negative serum pregnancy test (for women of child bearing age)
  • Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
  • IgG & IgM levels within normal limits
  • Adequate renal function as indicated by serum creatinine measurements.
  • No previous biological use (investigational or approved) except for the three approved anti-TNF alpha therapies
  • Patients who have been treated with anti-TNF alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry
  • No use of phosphodiesterase type 5 inhibitors (PDE5) (i.e. Sildenafil, Tadalafil, and Vardenafil) 1 week prior to the study and during the course of the study.
  • SBP ≤ 140/90 for two months prior to study enrollment

Exclusion Criteria:

  • Prior history of MI, CVA, CABG, PTCA, or peripheral vascular disease
  • Any serious concomitant medical condition that could interfere with the study.
  • Patients with insulin dependent diabetes
  • Failure to provide written consent.
  • Individuals with HIV infections
  • SBP > 140/90 at two months prior to study enrollment
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Please refer to this study by its identifier: NCT00844714

United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Genentech, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of California, San Francisco Identifier: NCT00844714     History of Changes
Other Study ID Numbers: RITUXANFMD
Study First Received: February 12, 2009
Results First Received: May 19, 2014
Last Updated: May 29, 2015

Keywords provided by University of California, San Francisco:
endothelial function
rheumatoid arthritis
cardiovascular risk
rituxan therapy

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 22, 2017