A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

This open-label, randomized, cross-over study evaluated 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 received OC in combination with TCZ, whereas the healthy volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8 mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The healthy volunteers received OC for only one 21-day cycle.

Key facts

Study ID

NCT01044498

Run by

Hoffmann-La Roche

People needed

46

Starts

2009-12-01

Expected to finish

2012-02-01

Last updated by the study team

2013-04-01

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Adult patients with child bearing potential, 18-44 years of age.
• Rheumatoid arthritis (RA) for over 6 months duration.
• On oral contraceptive without interruption for at least 3 months with normal cycle control.
• Treatment with disease-modifying anth-rheumatic drugs (DMARD) for at least 12 weeks prior to study start.
• Body weight < 150 kg.

You may not qualify if…

• Functional class IV rheumatoid arthritis (American College of Rheumatology [ACR] classification).
• History of amenorrhea (unrelated to pregnancy).
• History or current inflammatory joint disease other than RA.
• Rheumatic autoimmune disease other than RA.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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