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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

Page last updated: August 23, 2015

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