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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Priscilla Hsue, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00844714
First received: February 12, 2009
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Endothelial Function
Rheumatoid Arthritis
Inflammation
 Drug: Rituxan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • endothelial function as assessed by flow-mediated vasodilation of the brachial artery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituxan Drug: Rituxan
1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844714

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Genentech
  More Information

No publications provided

Responsible Party: Priscilla Hsue, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00844714     History of Changes
Other Study ID Numbers: RITUXANFMD
Study First Received: February 12, 2009
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
endothelial function
rheumatoid arthritis
cardiovascular risk
rituxan therapy

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Pathologic Processes
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013