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Terminated/Withdrawn
Sponsor ID
20110247

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

Sponsor ID
20110247
Clinicaltrials.gov ID
NCT02499315
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 1
Product
AMG 357
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
32
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 1 year

Secondary Outcome Measures

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

Timeframe: 1 year

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Duncansville, PA, United States, 16635
Status
Recruiting
Location
Research Site
Dallas, TX, United States, 75231
Status
Recruiting
Study Info
Age
25 - 70 Years
Condition
  • Rheumatoid Arthritis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Apr 2015 - Feb 2016
    Inclusion and Exclusion 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