- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02499315
Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis
May 5, 2016 updated by: Amgen
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
The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Research Site
-
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Texas
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Dallas, Texas, United States, 75231
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Oral tablets in 20 count bottles.
Dose strengths include 5, 25, and 50 mg tablets.
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Experimental: AMG 357
|
Oral tablets in 20 count bottles.
Dose strengths include 5, 25, and 50 mg tablets.
|
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome 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])
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
April 10, 2015
First Submitted That Met QC Criteria
July 14, 2015
First Posted (Estimate)
July 16, 2015
Study Record Updates
Last Update Posted (Estimate)
May 6, 2016
Last Update Submitted That Met QC Criteria
May 5, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20110247
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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