Effects of Denosumab on the Pharmacokinetics of Etanercept

Rheumatoid Arthritis Clinical Trial

Official title:

The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01294397
• Other study ID #: 20101324
• Status: Terminated
• Phase: Phase 1
• First received: January 13, 2011
• Last updated: March 8, 2016
• Start date: March 2011
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteopenia
• Osteoporosis
• Postmenopausal
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept
All 44 subjects will continue to receive a 50-mg dose of etanercept once weekly.
• Denosumab
All 44 subjects will receive a single 60-mg dose of denosumab.

Locations

Country	Name	City	State
United States	Research Site	Dallas	Texas
United States	Research Site	Duncansville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum concentration-time curve (AUC) from 0 to 168 hours for etanercept.		A period of 21 days following denosumab administration.	No
Primary	Maximum observed serum concentration (Cmax) for etanercept.		A period of 21 days following denosumab administration.	No
Secondary	Time to maximum serum concentration (tmax) for etanercept.		A period of 21 days following denosumab administration.	No
Secondary	Serum denosumab concentration.		At 14 and 21 days following denosumab administration.	No
Secondary	Serum C-telopeptide (sCTx) concentrations.		A period of 168 days following denosumab administration.	No

External Links

•   AmgenTrials clinical trials website