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

Not Applicable

Completed

• Conditions: Endothelial Function; Rheumatoid Arthritis; Inflammation
• Interventions: Drug: Rituxan

• Registration Number: NCT00844714
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Study Start: 2009-11
• Primary Completion: 2012-12
• Results First Submitted: 2014-05-19
• Results First Submitted QC: 2014-06-19
• Results First Posted: 2014-06-23
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituxan	Rituxan	-

Primary Outcome Measures

Name	Time	Method
Flow-mediated Vasodilation (FMD)	12 weeks, 24 weeks	endothelial function as assessed by flow-mediated vasodilation of the brachial artery

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States