Effects of Denosumab on the Pharmacokinetics of Etanercept

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab; Etanercept

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 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

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