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
| 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
| 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 weeksendothelial function as assessed by flow-mediated vasodilation of the brachial artery
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
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place