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

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

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