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Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMG 357
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject provided informed consent.
  • Rheumatoid arthritis present for ≥ 3 months.
  • Global functional class I, II, or III.
  • History of or positive for, Rheumatoid Arthritis
  • Taking methotrexate consecutively for ≥ 12 weeks and on a stable dose at 10-25 mg weekly.
  • Subjects currently taking NSAIDs or oral corticosteroids.
  • Normal ECG values
  • Immunizations up to date.

Exclusion Criteria:

  • Positive Hepatitis B, Hepatitis C, Positive HIV
  • Sensitivity to any of the products or components to be administered.
  • Malignancy within 3 years
  • Presence of recurrent or chronic infections
  • Evidence of infections within the 30 days prior to randomization
  • Presence of a serious infection
  • Prosthetic joint infection within 3 years or native joint infection within 1 year
  • History of exposure to tuberculosis without a history of prophylactic treatment
  • Class IV RA.
  • Felty's syndrome
  • Chronic pelvic pain or hemorrhagic ovarian cyst within 3 years
  • Any bleeding disorder that is clinically significant
  • Low white blood cell or neutrophil count
  • Elevated serum creatinine clearance
  • Low hemoglobin and platelet count
  • Received live vaccines within 3 months of first dose
  • Alcohol and/or substance abuse within past 12 months
  • Blood donation within 60 days
  • Positive urine screen for drugs of abuse
  • Any prior use of rituximab in the last 6 months (or other B cell depleting agents) and CD19 levels < lower limits of normal
  • Use of a weekly or bimonthly biologic within 2 weeks or monthly biologic agents within 4 weeks
  • Corticosteroid injections for acute RA flare within 4 weeks
  • Grapefruit juice or grapefruit containing products within 7 days of first dose.
  • All herbal medicines, vitamins, and supplements within the 30 days
  • The use of any experimental/investigational biologic DMARD unless off agent for 3 months; or off for 6 months for B cell depleting agents
  • Known GI disease or GI procedures
  • Women of reproductive potential who are unwilling to practice birth control
  • Women who are pregnant/lactating/breastfeeding
  • Subject with IgG levels < lower limit of normal at screening

Sites / Locations

  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMG 357

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs

Secondary Outcome Measures

AMG 357 pharmacokinetic profile (eg, plasma concentration, maximum observed concentration [Cmax], time at Cmax [Tmax], and area under the concentration-time curve [AUC])

Full Information

First Posted
April 10, 2015
Last Updated
May 5, 2016
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02499315
Brief Title
Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis
Official Title
A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Study has stopped due to a decision by Amgen to terminate the program
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AMG 357
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AMG 357
Intervention Description
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
Primary Outcome Measure Information:
Title
The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs
Time Frame
1 year
Secondary Outcome Measure Information:
Title
AMG 357 pharmacokinetic profile (eg, plasma concentration, maximum observed concentration [Cmax], time at Cmax [Tmax], and area under the concentration-time curve [AUC])
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject provided informed consent. Rheumatoid arthritis present for ≥ 3 months. Global functional class I, II, or III. History of or positive for, Rheumatoid Arthritis Taking methotrexate consecutively for ≥ 12 weeks and on a stable dose at 10-25 mg weekly. Subjects currently taking NSAIDs or oral corticosteroids. Normal ECG values Immunizations up to date. Exclusion Criteria: Positive Hepatitis B, Hepatitis C, Positive HIV Sensitivity to any of the products or components to be administered. Malignancy within 3 years Presence of recurrent or chronic infections Evidence of infections within the 30 days prior to randomization Presence of a serious infection Prosthetic joint infection within 3 years or native joint infection within 1 year History of exposure to tuberculosis without a history of prophylactic treatment Class IV RA. Felty's syndrome Chronic pelvic pain or hemorrhagic ovarian cyst within 3 years Any bleeding disorder that is clinically significant Low white blood cell or neutrophil count Elevated serum creatinine clearance Low hemoglobin and platelet count Received live vaccines within 3 months of first dose Alcohol and/or substance abuse within past 12 months Blood donation within 60 days Positive urine screen for drugs of abuse Any prior use of rituximab in the last 6 months (or other B cell depleting agents) and CD19 levels < lower limits of normal Use of a weekly or bimonthly biologic within 2 weeks or monthly biologic agents within 4 weeks Corticosteroid injections for acute RA flare within 4 weeks Grapefruit juice or grapefruit containing products within 7 days of first dose. All herbal medicines, vitamins, and supplements within the 30 days The use of any experimental/investigational biologic DMARD unless off agent for 3 months; or off for 6 months for B cell depleting agents Known GI disease or GI procedures Women of reproductive potential who are unwilling to practice birth control Women who are pregnant/lactating/breastfeeding Subject with IgG levels < lower limit of normal at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis

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