Completed
A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis
What is being tested
AMG 557
+ Matching Placebo
Drug
Who is being recruted
Autoimmune Diseases+2
+ Connective Tissue Diseases
+ Immune System Diseases
From 18 to 65 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 1
Interventional
Study Start: June 2012
Summary
Principal SponsorAmgen
Last updated: January 24, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2012
Actual date on which the first participant was enrolled.This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.
Principal SponsorAmgen
Last updated: January 24, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Autoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesSkin and Connective Tissue DiseasesLupus Erythematosus, Systemic
Criteria
3 inclusion criteria required to participate
Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
Other inclusion criteria may apply
Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) >= 6 at screening
6 exclusion criteria prevent from participating
Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
Other exclusion criteria may apply
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorAll will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
Group II
PlaceboAll will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Research Site
San Leandro, United StatesResearch Site
Danbury, United StatesResearch Site
Manhasset, United StatesCompleted13 Study Centers