Clinical trial NCT01683695: Safety Study of AMG 557 in Subjects With Lupus Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus Arthritis, Systemic Lupus Erythematosus
Keywords: Lupus Arthritis, Systemic Lupus Erythematosus, AMG 557, Lupus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
* 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;
* Other inclusion criteria may apply.

Exclusion Criteria:

* Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
* Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
* Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
* 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

Primary outcomes:
measure: Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.
timeFrame: 330 days, including a 21-day screening period
measure: Lupus Arthritis Response Rate
timeFrame: Day 169
Secondary outcomes:
measure: Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group.
timeFrame: Day 169
measure: Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.
timeFrame: Day 169
measure: Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline.
timeFrame: Days 85-169
measure: Proportion of subjects achieving reduction in and maintenance of prednisone (or its
timeFrame: Days 85-169
measure: Physician Global Assessment of Disease Activity (PGADA).
timeFrame: 330 days, including a 21-day screening period
measure: Subject Global Assessment of Disease Activity (SGADA).
timeFrame: 330 days, including a 21-day screening period
measure: Serum PK profile of AMG 557 after multiple dose administrations.
timeFrame: 330 days, including a 21-day screening period
measure: Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects
timeFrame: Day 29
measure: Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.
timeFrame: Day 85 to Day 169
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Leandro
country: United States
facility: Research Site
state: California
city: Danbury
country: United States
facility: Research Site
state: Connecticut
city: Manhasset
country: United States
facility: Research Site
state: New York
city: St Leonards
country: Australia
facility: Research Site
state: New South Wales
city: Odense
country: Denmark
facility: Research Site
city: Lille cedex 01
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Research Site
state: Wilayah Persekutuan
city: Taipei
country: Taiwan
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25.