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

Phase 1

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: AMG 357; Drug: Placebo

• Registration Number: NCT02499315
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 357	AMG 357	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs	1 year

Secondary Outcome Measures

Name	Time	Method
AMG 357 pharmacokinetic profile (eg, plasma concentration, maximum observed concentration [Cmax], time at Cmax [Tmax], and area under the concentration-time curve [AUC])	1 year

Trial Locations

Locations (1)

Research Site; 🇺🇸 Dallas, Texas, United States