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

Primary Purpose

Endothelial Function, Rheumatoid Arthritis, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rituxan
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endothelial Function focused on measuring endothelial function, rheumatoid arthritis, cardiovascular risk, rituxan therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituxan

Arm Description

Outcomes

Primary Outcome Measures

Flow-mediated Vasodilation (FMD)
endothelial function as assessed by flow-mediated vasodilation of the brachial artery

Secondary Outcome Measures

Full Information

First Posted
February 12, 2009
Last Updated
May 29, 2015
Sponsor
University of California, San Francisco
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00844714
Brief Title
Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
Official Title
Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Function, Rheumatoid Arthritis, Inflammation
Keywords
endothelial function, rheumatoid arthritis, cardiovascular risk, rituxan therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituxan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituxan
Intervention Description
1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study
Primary Outcome Measure Information:
Title
Flow-mediated Vasodilation (FMD)
Description
endothelial function as assessed by flow-mediated vasodilation of the brachial artery
Time Frame
12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25336464
Citation
Hsue PY, Scherzer R, Grunfeld C, Imboden J, Wu Y, Del Puerto G, Nitta E, Shigenaga J, Schnell Heringer A, Ganz P, Graf J. Depletion of B-cells with rituximab improves endothelial function and reduces inflammation among individuals with rheumatoid arthritis. J Am Heart Assoc. 2014 Oct 21;3(5):e001267. doi: 10.1161/JAHA.114.001267.
Results Reference
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Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

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