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Effects of Denosumab on the Pharmacokinetics of Etanercept

This study has been terminated.
(Lack of enrollment.)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01294397
First received: January 13, 2011
Last updated: April 5, 2017
Last verified: April 2017
  Purpose
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).

Condition Intervention Phase
Postmenopausal Osteopenia Rheumatoid Arthritis Osteoporosis Drug: Etanercept Drug: Denosumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Area Under the Serum Concentration-time Curve From 0 to 168 Hours (AUC0-168) for Etanercept [ Time Frame: Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. ]
    The AUC0-168 of etanercept was measured when administered alone (assessed from day 1) and after administration with denosumab (assessed from day 22, 14 days after denosumab dosing, close to the time of the maximum observed denosumab serum concentration and corresponding to a time approximately 1 week after maximal pharmacodynamic (PD) effects of denosumab are attained).

  • Maximum Observed Serum Concentration (Cmax) of Etanercept [ Time Frame: Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. ]

Secondary Outcome Measures:
  • Time to Maximum Serum Concentration (Tmax) of Etanercept [ Time Frame: Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose. ]
  • Serum Denosumab Concentration [ Time Frame: Prior to etanercept and denosumab dose administrations, as applicable, on days 8, 22, and 29 ]
  • Percent Change From Baseline in Serum C-telopeptide (sCTx) Concentrations [ Time Frame: Baseline (Day 8) and Days 22, 29, 85, and 176 ]

Enrollment: 19
Study Start Date: March 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etanercept + Denosumab
Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.
Drug: Etanercept
Administered by subcutaneous injection once a week
Other Name: Enbrel®
Drug: Denosumab
Administered by subcutaneous injection
Other Name: Prolia®

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294397

Locations
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Research Site
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01294397     History of Changes
Other Study ID Numbers: 20101324
Study First Received: January 13, 2011
Results First Received: December 14, 2016
Last Updated: April 5, 2017

Keywords provided by Amgen:
Amgen
Phase 1
Postmenopausal
Osteopenia
Rheumatoid
Bone Mineral Density
Arthritis
Pharmacokinetics
Osteoporosis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoporosis
Bone Diseases, Metabolic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases
Etanercept
Denosumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 25, 2017