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

May 5, 2016 updated by: Amgen

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
Experimental: AMG 357
Drug: AMG 357
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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