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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Contraceptive Agents; Contraceptives, Oral; Mestranol; Norethindrone; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.