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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02499315
• Other study ID #: 20110247
• Status: Terminated
• Phase: Phase 1
• First received: April 10, 2015
• Last updated: May 5, 2016
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AMG 357
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
• Placebo
Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.

Locations

Country	Name	City	State
United States	Research Site	Dallas	Texas
United States	Research Site	Duncansville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

•   AmgenTrials clinical trials website