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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02159053




Registration number
NCT02159053
Ethics application status
Date submitted
28/02/2014
Date registered
9/06/2014

Titles & IDs
Public title
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing Spondylitis
Secondary ID [1] 0 0
2013-005575-41
Secondary ID [2] 0 0
CAIN457F2320
Universal Trial Number (UTN)
Trial acronym
MEASURE4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spondylitis, Ankylosing 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Secukinumab
Treatment: Other - Secukinumab
Treatment: Other - Placebo

Experimental: Secukinumab 150 mg s.c. with loading - Secukinumab 150 mg at Baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4.

Experimental: Secukinumab 150 mg s.c. without loading - Secukinumab 150 mg at Baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2, and 3.

Placebo comparator: Placebo - Placebo at Baseline, Weeks 1, 2, 3, 4, 8, and 12, followed by dosing with Secukinumab 150 mg every four weeks starting at Week 16.


Treatment: Other: Secukinumab
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Treatment: Other: Secukinumab
Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio

Treatment: Other: Placebo
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks
Timepoint [1] 0 0
16 Weeks
Secondary outcome [1] 0 0
Percentage of Participants Responded for ASAS 40 Response at 16 Weeks
Timepoint [1] 0 0
16 Weeks
Secondary outcome [2] 0 0
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks
Timepoint [2] 0 0
Baseline, 16 Weeks
Secondary outcome [3] 0 0
Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks
Timepoint [3] 0 0
16 Weeks
Secondary outcome [4] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks
Timepoint [4] 0 0
Baseline, 16 Weeks
Secondary outcome [5] 0 0
Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)
Timepoint [5] 0 0
Baseline, 16 Weeks
Secondary outcome [6] 0 0
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks
Timepoint [6] 0 0
Baseline, 16 Weeks
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks
Timepoint [7] 0 0
104 Weeks
Secondary outcome [8] 0 0
Percentage of Participants Responded for ASAS 20 at Week 4
Timepoint [8] 0 0
Week 4
Secondary outcome [9] 0 0
Percentage of Participants Responded for ASAS 40 Response at Week 4
Timepoint [9] 0 0
Week 4

Eligibility
Key inclusion criteria
Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.

Other protocol-defined inclusion/exclusion criteria do 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 3
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
18/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/01/2018
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [2] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [3] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [4] 0 0
Novartis Investigative Site - Malvern East
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Austria
State/province [13] 0 0
Graz
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Pleven
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Plovdiv
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Targovishte
Country [19] 0 0
Canada
State/province [19] 0 0
Manitoba
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Czechia
State/province [21] 0 0
Czech Republic
Country [22] 0 0
Denmark
State/province [22] 0 0
Frederiksberg
Country [23] 0 0
Denmark
State/province [23] 0 0
Odense
Country [24] 0 0
Finland
State/province [24] 0 0
Hyvinkaa
Country [25] 0 0
Finland
State/province [25] 0 0
Jyvaskyla
Country [26] 0 0
Germany
State/province [26] 0 0
Lower Saxony
Country [27] 0 0
Germany
State/province [27] 0 0
Bad Doberan
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Chemnitz
Country [30] 0 0
Germany
State/province [30] 0 0
Erlangen
Country [31] 0 0
Germany
State/province [31] 0 0
Germering
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Herne
Country [34] 0 0
Germany
State/province [34] 0 0
Leipzig
Country [35] 0 0
Germany
State/province [35] 0 0
Magdeburg
Country [36] 0 0
Germany
State/province [36] 0 0
Muenchen
Country [37] 0 0
Germany
State/province [37] 0 0
Wurzburg
Country [38] 0 0
Greece
State/province [38] 0 0
Athens
Country [39] 0 0
Greece
State/province [39] 0 0
Patras
Country [40] 0 0
Italy
State/province [40] 0 0
GE
Country [41] 0 0
Italy
State/province [41] 0 0
MI
Country [42] 0 0
Italy
State/province [42] 0 0
TO
Country [43] 0 0
Italy
State/province [43] 0 0
VR
Country [44] 0 0
Netherlands
State/province [44] 0 0
Amsterdam
Country [45] 0 0
Netherlands
State/province [45] 0 0
Heerlen
Country [46] 0 0
Netherlands
State/province [46] 0 0
Leiden
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Netherlands
State/province [47] 0 0
Rotterdam
Country [48] 0 0
Norway
State/province [48] 0 0
Kongsvinger
Country [49] 0 0
Poland
State/province [49] 0 0
Bialystok
Country [50] 0 0
Poland
State/province [50] 0 0
Elblag
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Poland
State/province [51] 0 0
Poznan
Country [52] 0 0
Poland
State/province [52] 0 0
Warszawa
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Barnaul
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Russian Federation
State/province [54] 0 0
Kemerovo
Country [55] 0 0
Russian Federation
State/province [55] 0 0
S.-Petersburg
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saint Petersburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
St-Petersburg
Country [58] 0 0
Slovakia
State/province [58] 0 0
SVK
Country [59] 0 0
Slovakia
State/province [59] 0 0
Partizanske
Country [60] 0 0
Slovakia
State/province [60] 0 0
Sabinov
Country [61] 0 0
Slovakia
State/province [61] 0 0
Stara Lubovna
Country [62] 0 0
Slovakia
State/province [62] 0 0
Topolcany
Country [63] 0 0
Spain
State/province [63] 0 0
Andalucia
Country [64] 0 0
Spain
State/province [64] 0 0
Barcelona
Country [65] 0 0
Spain
State/province [65] 0 0
Cantabria
Country [66] 0 0
Spain
State/province [66] 0 0
Galicia
Country [67] 0 0
Spain
State/province [67] 0 0
Vizcaya
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Switzerland
State/province [69] 0 0
Fribourg
Country [70] 0 0
Switzerland
State/province [70] 0 0
St Gallen
Country [71] 0 0
United Kingdom
State/province [71] 0 0
London
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Doncaster
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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 are available at https://clinicaltrials.gov/study/NCT02159053