Phase 3
Completed N=46
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01044498 ↗Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Mar 2013
Primary outcomePrimary: Serum Progesterone Level — 0.21; 0.57; 0.22; NA ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Progesterone Level |
0.21; 0.57; 0.22; NA; 0.19; NA | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone |
183; 157; 163; NA; 177; NA | — |
| SECONDARY Time to Reach the Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethindrone |
1.42; 1.28; 1.90; NA; 1.58; NA | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Ethinyl Estradiol and Norethindrone |
1387; 1389; 1409; NA; 1455; NA | — |
| SECONDARY Terminal Half-life (t½) of Ethinyl Estradiol and Norethindrone |
14.71; 17.05; 14.70; NA; 15.24; NA | — |
| SECONDARY Apparent Oral Clearance (CL/F) of Ethinyl Estradiol and Norethindrone |
28.49; 28.64; 29.23; NA; 26.86; NA | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Tocilizumab |
204 | — |
| SECONDARY Time to Reach Maximum Serum Concentration (Tmax) of Tocilizumab |
4.41 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From 0 to Infinity (AUCinf) of Tocilizumab |
35038 | — |
| SECONDARY Terminal Half-life (t½) of Tocilizumab |
145.92 | — |
| SECONDARY Clearance (CL) of Tocilizumab |
17.51 | — |
| SECONDARY Apparent Volume of Distribution (Vz) of Tocilizumab |
3.60 | — |
| SECONDARY Serum Soluble Interleukin-6 Receptor (sIL-6R) Level |
38.5; 100.6; 162.5; 249.1; 312.9; 425.1 | — |
| SECONDARY Serum C-reactive Protein (CRP) Level |
16.86; 12.76; 7.53; 4.62; 3.90; 3.95 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01044498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.