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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844714
• Other study ID #: RITUXANFMD
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: May 29, 2015
• Start date: November 2009
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Endothelial Function
• Inflammation
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated Vasodilation (FMD)	endothelial function as assessed by flow-mediated vasodilation of the brachial artery	12 weeks, 24 weeks	No