NCT00844714CompletedNot Applicable
Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
University of California, San Francisco1 site in 1 country20 target enrollmentStarted: November 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Flow-mediated Vasodilation (FMD)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Rituxan
Experimental
Intervention: Rituxan (Drug)
Outcomes
Primary Outcomes
Flow-mediated Vasodilation (FMD)
Time Frame: 12 weeks, 24 weeks
endothelial function as assessed by flow-mediated vasodilation of the brachial artery
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Cardiovascular Risk Factors in Rheumatoid Arthritis Patients ( Comparison Between Seronegative and Seropositive Cases )Rheumatoid ArthritisNCT06738264Sohag University100
Completed
Phase 3
Rituximab in Rheumatoid Arthritis Lung DiseaseRheumatoid ArthritisInterstitial PneumoniaNCT00578565Eric Matteson10
Completed
Not Applicable
A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)Rheumatoid ArthritisNCT00443443Genentech, Inc.1,026
Completed
Not Applicable
Study of Infections in Patients With Autoimmune Diseases Treated With RituximabAutoimmune DiseasesNCT03778840University Hospital, Lille73
Active, not recruiting
Not Applicable
Cardiovascular Risk and Chronic Inflammatory RheumatismRheumatologyCardiovascular DiseasesArthritis, RheumatoidSpondyloarthritisNCT03187444University Hospital, Clermont-Ferrand200