Effects of Denosumab on the Pharmacokinetics of Etanercept
Stopped early · Phase 1
Conditions studied: Postmenopausal, Osteopenia, Rheumatoid Arthritis, Osteoporosis
In brief
The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum observed serum concentration (Cmax).
Key facts
- Study ID
- NCT01294397
- Run by
- Amgen
- People needed
- 19
- Starts
- 2011-03-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-06-20
Who can join
Age: 45 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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 end of study (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
You may not qualify if…
- 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
Where it is running
- Research Site — Duncansville, Pennsylvania, United States
- Research Site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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