Clinical trial NCT02499315: Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 32
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: