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

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Ortho-Novum® 1/35

Drug: Tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01044498

NP22775

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

Female

Ages

18 to 44 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 2 patient groups

Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)

Experimental group

Description:

Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.

Treatment:

Drug: Tocilizumab

Drug: Ortho-Novum® 1/35

Ortho-Novum® 1/35 (Group 2)

Other group

Description:

Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.

Treatment:

Drug: Ortho-Novum® 1/35