Study Stopped
Study has stopped due to a decision by Amgen to terminate the program
Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis
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
1 other identifier
interventional
32
1 country
2
Brief Summary
The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 rheumatoid-arthritis
Started Apr 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 6, 2016
May 1, 2016
10 months
April 10, 2015
May 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
AMG 357
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (2)
Research Site
Duncansville, Pennsylvania, 16635, United States
Research Site
Dallas, Texas, 75231, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2015
First Posted
July 16, 2015
Study Start
April 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
May 6, 2016
Record last verified: 2016-05