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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01683695




Registration number
NCT01683695
Ethics application status
Date submitted
14/03/2012
Date registered
12/09/2012
Date last updated
24/01/2017

Titles & IDs
Public title
Safety Study of AMG 557 in Subjects With Lupus Arthritis
Scientific 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
Secondary ID [1] 0 0
20101103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Arthritis, Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 557
Treatment: Drugs - Matching Placebo

Active Comparator: AMG 557 - All 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.

Placebo Comparator: AMG 557 Matching Placebo - All 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.


Treatment: Drugs: AMG 557
AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.

Treatment: Drugs: Matching Placebo
Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.
Timepoint [1] 0 0
330 days, including a 21-day screening period
Primary outcome [2] 0 0
Lupus Arthritis Response Rate
Timepoint [2] 0 0
Day 169
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 169
Secondary outcome [2] 0 0
Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.
Timepoint [2] 0 0
Day 169
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Days 85-169
Secondary outcome [4] 0 0
Proportion of subjects achieving reduction in and maintenance of prednisone (or its
Timepoint [4] 0 0
Days 85-169
Secondary outcome [5] 0 0
Physician Global Assessment of Disease Activity (PGADA).
Timepoint [5] 0 0
330 days, including a 21-day screening period
Secondary outcome [6] 0 0
Subject Global Assessment of Disease Activity (SGADA).
Timepoint [6] 0 0
330 days, including a 21-day screening period
Secondary outcome [7] 0 0
Serum PK profile of AMG 557 after multiple dose administrations.
Timepoint [7] 0 0
330 days, including a 21-day screening period
Secondary outcome [8] 0 0
Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects
Timepoint [8] 0 0
Day 29
Secondary outcome [9] 0 0
Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.
Timepoint [9] 0 0
Day 85 to Day 169

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Denmark
State/province [4] 0 0
Odense
Country [5] 0 0
France
State/province [5] 0 0
Lille cedex 01
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Malaysia
State/province [7] 0 0
Sarawak
Country [8] 0 0
Malaysia
State/province [8] 0 0
Wilayah Persekutuan
Country [9] 0 0
Taiwan
State/province [9] 0 0
Taipei
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Birmingham
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01683695
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01683695