Effects of Denosumab on the Pharmacokinetics of Etanercept
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal; Osteopenia; Rheumatoid Arthritis; Osteoporosis
Intervention: Etanercept (Drug); Denosumab (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Overall contact: Amgen Call Center, Phone: 866-572-6436
Summary
This is a multi-center, open-label, single sequence, denosumab single-dose study in
postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis (RA) being
treated with etanercept.
Clinical Details
Official title: The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under the serum concentration-time curve (AUC) from 0 to 168 hours for etanercept.Maximum observed serum concentration (Cmax) for etanercept.
Secondary outcome: Time to maximum serum concentration (tmax) for etanercept.Serum denosumab concentration. Serum C-telopeptide (sCTx) concentrations.
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Postmenopausal women (postmenopausal is defined as no vaginal bleeding or spotting
for at least 12 months)
- Low bone mineral density (BMD) as determined by screening BMD T-scores of the lumbar
spine (L1 to L4), or total evaluable vertebrae (if fewer than L1 to L4), or total hip
≤ - 1. 0
- Receiving a 50-mg dose of etanercept once weekly ≥ 6 months prior to screening and
expected to continue etanercept treatment at this dose and frequency through EOS
- If currently taking methotrexate (MTX), receiving a stable dose (7. 5 to 20 mg/week)
of MTX ≥ 8 weeks prior to screening
- Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 400 IU vitamin D daily
upon enrollment
Exclusion Criteria:
- Type 1 diabetes; OR poorly controlled Type 2 diabetes (hemoglobin A1c (HbA1c) > 8. 0%
at screening; HbA1c ≤ 8. 0% within 6 months of screening is acceptable if supporting
laboratory documentation is available)
- History of heart failure, coronary artery bypass graft, or cardiac arrhythmia; OR
history of acute coronary syndrome
- Comorbid autoimmune disease, demyelinating disease, or hematologic abnormalities
- History of joint replacement in hand and/or wrist; OR history of fused joint in hand
and/or wrist
- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw; OR
active dental or jaw condition that requires oral surgery, or non-healed dental/oral
surgery; OR planned invasive dental procedure(s) during the course of the study
- Previous exposure to denosumab
Locations and Contacts
Amgen Call Center, Phone: 866-572-6436
Research Site, Duncansville, Pennsylvania 16635, United States; Recruiting
Research Site, Dallas, Texas 75231, United States; Recruiting
Additional Information
AmgenTrials clinical trials website
Starting date: March 2011
Last updated: March 12, 2015
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