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OpenTrials
Completed

NCT Number: NCT00844714

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituxan

Drug

1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study

Primary outcomes

  1. Flow-mediated Vasodilation (FMD)

    Time frame: 12 weeks, 24 weeks

    endothelial function as assessed by flow-mediated vasodilation of the brachial artery

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Genentech, Inc.

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Feb 16, 2009
Registry last updated
Jun 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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