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

Amgen

Status and phase

Terminated

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: AMG 357

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02499315

20110247

Details and patient eligibility

About

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

Enrollment

32 estimated patients

Sex

Female

Ages

25 to 70 years old

Volunteers

No 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