A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
| Status: | Archived |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2010 |
| End Date: | January 2012 |
An Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA)
This open-label, randomized, cross-over study will evaluate the effect of tocilizumab (TCZ)
on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female
patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child
bearing age. The RA patients will receive OC in combination with TCZ, whereas the healthy
volunteers will receive OC only. OC will be administered in 3 cycles of 21 days each. TCZ 8
mg/kg will be administered once as an intravenously infusion on the first day of the second
cycle. The anticipated time of study treatment will be <12 months. The target sample size is
<100 patients and healthy volunteers.
We found this trial at
5
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials