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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Hoffmann-La Roche
Study ID
NCT01044498
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab 8 mg/kg was administered in a single 1-hour infusion on Day 1 of Cycle 2.
  • Ortho-Novum® 1/35 — DRUG
    Each Ortho-Novum® 1/35 tablet contained 1 mg of norethindrone and 0.035 mg of ethinyl estradiol.

Study Details

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 Dates

Start date
Dec 31, 2009
Status verified
Mar 2013
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)
    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.
  • Other: Ortho-Novum® 1/35 (Group 2)
    Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.

Primary Outcome Measure

Serum Progesterone Level [ Time Frame: Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2 ]

Locations (6)

FacilityCityStateZIPSite coordinators
-Little RockArkansas72212-
-Beverly HillsCalifornia90211-
-Ormond BeachFlorida32174-
-Port OrangeFlorida32127-
-DuncansvillePennsylvania16635-
-San AntonioTexas78222-

Find similar trials in Little Rock, AR

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

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