Trial Outcomes & Findings for Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy (NCT NCT00844714)

NCT ID: NCT00844714

Last Updated: 2015-06-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

12 weeks, 24 weeks

Results posted on

2015-06-26

Participant Flow

Participant milestones

Participant milestones
Measure
Rituxan
Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
Overall Study
STARTED
20
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rituxan
n=20 Participants
Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
Age, Continuous
54 years
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
19 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
Flow-mediated vasodilation (FMD)
3.9 mm
n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks, 24 weeks

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

Outcome measures

Outcome measures
Measure
Rituxan
n=20 Participants
Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
Flow-mediated Vasodilation (FMD)
12 weeks
6.1 percentage change in diameter
Interval 4.9 to 7.6
Flow-mediated Vasodilation (FMD)
24 weeks
4.4 percentage change in diameter
Interval 3.3 to 6.1

Adverse Events

Rituxan

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Priscilla Hsue, MD

University of California, San Francisco

Phone: 415-206-8257

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place