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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Tocilizumab (Drug); Ortho-Novum® 1/35 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Serum Progesterone Level

Secondary outcome:

Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone

Time to Reach the Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethindrone

Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Ethinyl Estradiol and Norethindrone

Terminal Half-life (t½) of Ethinyl Estradiol and Norethindrone

Apparent Oral Clearance (CL/F) of Ethinyl Estradiol and Norethindrone

Maximum Observed Serum Concentration (Cmax) of Tocilizumab

Time to Reach Maximum Serum Concentration (Tmax) of Tocilizumab

Area Under the Serum Concentration-time Curve From 0 to Infinity (AUCinf) of Tocilizumab

Terminal Half-life (t½) of Tocilizumab

Clearance (CL) of Tocilizumab

Apparent Volume of Distribution (Vz) of Tocilizumab

Serum Soluble Interleukin-6 Receptor (sIL-6R) Level

Serum C-reactive Protein (CRP) Level

Eligibility

Minimum age: 18 Years. Maximum age: 44 Years. Gender(s): Female.

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.

Locations and Contacts

Little Rock, Arkansas 72212, United States

Beverly Hills, California 90211, United States

Ormond Beach, Florida 32174, United States

Port Orange, Florida 32127, United States

Duncansville, Pennsylvania 16635, United States

San Antonio, Texas 78222, United States

Additional Information

Starting date: December 2009
Last updated: March 22, 2013

Page last updated: August 23, 2015

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