Rheumatoid Arthritis
Conditions
Brief summary
The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis.
Interventions
DRUGAMG 357
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
DRUGPlacebo
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed