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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT00844714
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 61
• Patients Per Site Per Month: 0.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Endothelial Function; Rheumatoid Arthritis; Inflammation	Drug: Rituxan	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rituxan	Drug: Rituxan; 1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study

Outcome Measures

Primary Outcome Measures

1. Flow-mediated Vasodilation (FMD) [12 weeks, 24 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94110

Sponsors and Collaborators

• University of California, San Francisco
• Genentech, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00844714
• Other Study ID Numbers: RITUXANFMD
• First Posted: Feb 16, 2009
• Last Update Posted: Jun 26, 2015
• Last Verified: May 1, 2015

• Keywords provided by University of California, San Francisco: endothelial function; rheumatoid arthritis; cardiovascular risk; rituxan therapy
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation; Rituximab

Study Results

Participant Flow

Arm/Group Title	Rituxan
Arm/Group Description	Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Rituxan
Arm/Group Description	Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
Overall Participants	20
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	54
Sex: Female, Male (Count of Participants)
Female	1 5%
Male	19 95%
Region of Enrollment (participants) [Number]
United States	20 100%
Flow-mediated vasodilation (FMD) (mm) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mm]	3.9

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rituxan
Arm/Group Description	Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
Measure Participants	20
12 weeks	6.1
24 weeks	4.4

Adverse Events

Arm/Group Title	Rituxan
Arm/Group Description	Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
All Cause Mortality
	Rituxan
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Rituxan
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Rituxan
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.