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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT02499315

Run by

Amgen

People needed

32

Starts

2015-04-01

Expected to finish

2016-02-01

Last updated by the study team

2016-05-06

Who can join

Age: 25 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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