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.
Read more: http://www.clinicaltrials.gov/ct2/show/NCT01044498?cond=%22Arthritis%22&lup_s=07/14/2011&lup_d=30
