NCT00844714

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 23, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 26, 2015

Status Verified

May 1, 2015

Enrollment Period

3.1 years

First QC Date

February 12, 2009

Results QC Date

May 19, 2014

Last Update Submit

May 29, 2015

Conditions

Endothelial FunctionRheumatoid ArthritisInflammation

Keywords

endothelial functionrheumatoid arthritiscardiovascular riskrituxan therapy

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated Vasodilation (FMD)

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

    12 weeks, 24 weeks

Study Arms (1)

Rituxan

EXPERIMENTAL
Drug: Rituxan

Interventions

RituxanDRUG

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

Rituxan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • 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.

    PMID: 25336464DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidInflammation

Interventions

Rituximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Priscilla Hsue, MD
Organization
University of California, San Francisco
phsue@medsfgh.ucsf.edu
415-206-8257

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 16, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2014

Last Updated

June 26, 2015

Results First Posted

June 23, 2014

Record last verified: 2015-05

Locations

US(1)