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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04058028




Registration number
NCT04058028
Ethics application status
Date submitted
30/07/2019
Date registered
15/08/2019

Titles & IDs
Public title
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
Scientific title
A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
Secondary ID [1] 0 0
20170588
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus (SLE) 0 0
Condition category
Condition code
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 - Rozibafusp Alfa
Treatment: Drugs - Placebo for Rozibafusp Alfa

Experimental: Rozibafusp Alfa, Dose A - Investigational product solution in vial

Experimental: Rozibafusp Alfa, Dose B - Investigational product solution in vial

Experimental: Rozibafusp Alfa, Dose C - Investigational product solution in vial

Placebo comparator: Placebo for Rozibafusp Alfa - Placebo Investigational product solution in vial


Treatment: Drugs: Rozibafusp Alfa
Rozibafusp Alfa will be presented in 5 mL glass vial

Treatment: Drugs: Placebo for Rozibafusp Alfa
Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of patients achieving Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response at week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percent of patients achieving a SRI-4 response at week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percent of patients achieving Lupus Low Disease Activity State (LLDAS) at week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percent of patients achieving The British Isles Lupus Assessment Group (BILAG) based Combined Lupus Assessment (BICLA) index responses
Timepoint [3] 0 0
Week 24 and Week 52
Secondary outcome [4] 0 0
SRI-4 at week 52 with reduction of OCS to less than or equal to 7.5 mg/day by week 44 and sustained through week 52 in subjects with a baseline OCS dose = 10 mg/day
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Annualized moderate and severe flare rate
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
Annualized severe flare rate
Timepoint [6] 0 0
52 weeks
Secondary outcome [7] 0 0
Annualized flare rate
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
Total tender and swollen joint count (limited to hands and wrists): = 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with = 6 tender and swollen joints in the hands and wrists at baseline
Timepoint [8] 0 0
Baseline, Week 12, 24, 36, and 52
Secondary outcome [9] 0 0
Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) activity score = 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with a CLASI activity score = 8 at baseline
Timepoint [9] 0 0
Baseline, Week 12, 24, 36, and 52
Secondary outcome [10] 0 0
Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7A) score change from baseline
Timepoint [10] 0 0
Baseline, Week 12, 24, 36, 44 and 52
Secondary outcome [11] 0 0
Medical Outcomes Short Form 36 version 2 Questionnaire (SF-36v2) physical component score change from baseline
Timepoint [11] 0 0
Baseline, Week 12, 24, 36, 44 and 52
Secondary outcome [12] 0 0
Medical Outcomes Short Form 36 version 2 Questionnaire (SF-36v2) mental component score individual domains change from baseline
Timepoint [12] 0 0
Baseline, Week 12, 24, 36, 44 and 52
Secondary outcome [13] 0 0
Lupus Quality of Life (QoL) score and change from baseline
Timepoint [13] 0 0
Baseline, Week 12, 24, 36, 44 and 52
Secondary outcome [14] 0 0
Patient Global Assessment (PtGA) score change from baseline
Timepoint [14] 0 0
Baseline, Week 12, 24, 36, 44 and 52
Secondary outcome [15] 0 0
Patient incidence of Treatment-Emergent Adverse Events
Timepoint [15] 0 0
52 weeks
Secondary outcome [16] 0 0
Patient incidence of Serious adverse events
Timepoint [16] 0 0
52 weeks
Secondary outcome [17] 0 0
Number of patients with significant changes in laboratory values
Timepoint [17] 0 0
52 weeks
Secondary outcome [18] 0 0
Number of patients with significant changes in vital signs
Timepoint [18] 0 0
52 weeks
Secondary outcome [19] 0 0
Serum Rozibafusp Alfa trough concentrations
Timepoint [19] 0 0
52 Weeks
Secondary outcome [20] 0 0
Rozibafusp Alfa terminal elimination half-life, if possible
Timepoint [20] 0 0
52 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria Screening Visit:

* Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
* Age = 18 years to = 75 years at screening visit.
* Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody = 1:80 by immunofluorescence on Hep-2 cells being present at screening.
* Hybrid SLEDAI score = 6 points with a "Clinical" hSLEDAI score = 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
* Additional protocol-specific rules are applied at screening and throughout the study, as follows:

* Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring.
* Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia = 2.
* Oral ulcers: Ulcers location and appearance must be documented by the investigator.
* Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded.
* Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI = 4 and did not receive induction treatment for nephritis within the last year.
* Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI.
* Unless there is a documented intolerance, subjects must be taking:

* Only 1 of the following SLE treatments: anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone.

OR

• 2 of the above-mentioned SLE treatments in which 1 must be anti-malarial (hydroxychloroquine, chloroquine, or quinacrine).

* Treatment should be taken for = 12 weeks prior to screening and must be a stable dose for = 8 weeks prior to screening.
* For subjects taking OCS, dose must be = 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit for = 2 weeks prior to screening visit.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria Screening Visit

Subjects are excluded from the study if any of the following criteria apply:

Disease Related

* Urine protein creatinine ratio = 3000 mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit.
* Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
19/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/07/2023
Sample size
Target
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Louisiana
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Maryland
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New York
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North Carolina
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Distrito Federal
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Argentina
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Tucuman
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Argentina
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San Juan
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Alberta
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Canada
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Manitoba
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Canada
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Quebec
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Czechia
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Praha 2
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France
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Bordeaux
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France
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Caen Cedex 9
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France
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Dijon Cedex
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France
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Lille cedex 01
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France
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Paris
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France
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Reims Cedex
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France
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Strasbourg
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France
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Toulouse Cedex 9
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France
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Toulouse
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Germany
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Bad Kreuznach
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Germany
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Leipzig
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Patra
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Hong Kong
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New Territories
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Szekesfehervar
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Milano
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Italy
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Pisa
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Italy
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Roma
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Rozzano MI
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Chiba
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Fukuoka
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Hyogo
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Ishikawa
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Miyagi
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Nagano
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Nagasaki
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Okayama
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Tokyo
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Korea, Republic of
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Daegu
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Seoul
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Suwon-si, Gyeonggi-do
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Baja California Norte
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Jalisco
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Mexico
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Yucatán
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Mexico
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Ciudad de Mexico
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Poland
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Gdansk
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Gdynia
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Katowice
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Krakow
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Lodz
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Lublin
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Poznan
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Stalowa Wola
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Warszawa
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Wroclaw
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Portugal
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Almada
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Spain
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Andalucía
Country [91] 0 0
Spain
State/province [91] 0 0
Cataluña
Country [92] 0 0
Spain
State/province [92] 0 0
Galicia

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04058028