Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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
Query!
Secondary ID [1]
0
0
2013-005575-41
Query!
Secondary ID [2]
0
0
CAIN457F2320
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MEASURE4
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Spondylitis, Ankylosing
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks
Query!
Assessment method [1]
0
0
ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20 percent (%) and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)
Query!
Timepoint [1]
0
0
16 Weeks
Query!
Secondary outcome [1]
0
0
Percentage of Participants Responded for ASAS 40 Response at 16 Weeks
Query!
Assessment method [1]
0
0
ASAS 20 response is a validated composite assessment, defined as an improvement of at least 40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include:
1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe
2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain
3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale
4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem).
Query!
Timepoint [1]
0
0
16 Weeks
Query!
Secondary outcome [2]
0
0
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks
Query!
Assessment method [2]
0
0
Blood levels of C-reactive protein (CRP) is an acute phase reactant, which are indicative of inflammation and of its severity, and can be used to monitor treatment response. A hsCRP test is implemented to assess the efficacy of secukinumab (with or without load) versus placebo in reducing ankylosing spondylitis elicited systemic inflammation over the time.
Query!
Timepoint [2]
0
0
Baseline, 16 Weeks
Query!
Secondary outcome [3]
0
0
Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks
Query!
Assessment method [3]
0
0
ASAS 5/6 response is a validated composite assessment, defined as an improvement of at least 20% in score in at least 5 of 6 clinical domains relevant to ankylosing spondylitis and no worsening in the remaining domain. ASAS domains includes:
1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe
2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain
3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale
4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)
5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment
6. C-reactive protein (CRP, acute phase reactant).
Query!
Timepoint [3]
0
0
16 Weeks
Query!
Secondary outcome [4]
0
0
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks
Query!
Assessment method [4]
0
0
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem" on continuous VAS), to answer 6 questions (clinical domains) pertaining to 5 major symptoms of ankylosing spondylitis. Computed composite scores of 4 or greater indicate suboptimal disease control. BASDAI questions includes:
1. Fatigue
2. Spinal pain
3. Joint pain / swelling
4. Areas of localized tenderness (called enthesitis, or inflammation of tendons and ligaments)
5. Morning stiffness duration
6. Morning stiffness severity. Each symptom has equal weighting, the mean of two scores related to morning stiffness was taken (questions 5 and 6). The resulting 0 to 10 score was added to the scores from questions 1-4. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score. BASDAI was a quick and simple index taking between 30 seconds and 2 minutes for completion.
Query!
Timepoint [4]
0
0
Baseline, 16 Weeks
Query!
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)
Query!
Assessment method [5]
0
0
SF-36 is a 36 item questionnaire which measures Quality of Life across eight subscales that were scored individually: physical functioning, role- physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability. The overall summary scores, SF-36 physical Component Summary (PCS) was used to assess improvement from baseline in the Health-Related Quality Of Life of subjects. The change in SF-36 scores were evaluated using MMRM.
Query!
Timepoint [5]
0
0
Baseline, 16 Weeks
Query!
Secondary outcome [6]
0
0
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks
Query!
Assessment method [6]
0
0
ASQoL is a self-administered 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a subject with ankylosing spondylitis: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score ranges from 0 (good QoL) to 18 (poor QoL). The change in ASQoL scores was evaluated using a mixed effect repeated measures model (MMRM).
Query!
Timepoint [6]
0
0
Baseline, 16 Weeks
Query!
Secondary outcome [7]
0
0
Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks
Query!
Assessment method [7]
0
0
AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Query!
Timepoint [7]
0
0
104 Weeks
Query!
Secondary outcome [8]
0
0
Percentage of Participants Responded for ASAS 20 at Week 4
Query!
Assessment method [8]
0
0
ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20% and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include:
1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe
2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain
3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale
4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem).
Query!
Timepoint [8]
0
0
Week 4
Query!
Secondary outcome [9]
0
0
Percentage of Participants Responded for ASAS 40 Response at Week 4
Query!
Assessment method [9]
0
0
ASAS 20 response is a validated composite assessment, defined as an improvement of at least 40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include:
1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe
2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain
3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale
4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem).
Query!
Timepoint [9]
0
0
Week 4
Query!
Eligibility
Key inclusion criteria
Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/05/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
2/01/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
350
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Kogarah
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Maroochydore
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Hobart
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Malvern East
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [3]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [4]
0
0
3145 - Malvern East
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Nebraska
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Oklahoma
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
South Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Washington
Query!
Country [13]
0
0
Austria
Query!
State/province [13]
0
0
Graz
Query!
Country [14]
0
0
Austria
Query!
State/province [14]
0
0
Vienna
Query!
Country [15]
0
0
Bulgaria
Query!
State/province [15]
0
0
Pleven
Query!
Country [16]
0
0
Bulgaria
Query!
State/province [16]
0
0
Plovdiv
Query!
Country [17]
0
0
Bulgaria
Query!
State/province [17]
0
0
Sofia
Query!
Country [18]
0
0
Bulgaria
Query!
State/province [18]
0
0
Targovishte
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Manitoba
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Quebec
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Czech Republic
Query!
Country [22]
0
0
Denmark
Query!
State/province [22]
0
0
Frederiksberg
Query!
Country [23]
0
0
Denmark
Query!
State/province [23]
0
0
Odense
Query!
Country [24]
0
0
Finland
Query!
State/province [24]
0
0
Hyvinkaa
Query!
Country [25]
0
0
Finland
Query!
State/province [25]
0
0
Jyvaskyla
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Lower Saxony
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Bad Doberan
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Berlin
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Chemnitz
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Erlangen
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Germering
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Hamburg
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Herne
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Leipzig
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Magdeburg
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Muenchen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Wurzburg
Query!
Country [38]
0
0
Greece
Query!
State/province [38]
0
0
Athens
Query!
Country [39]
0
0
Greece
Query!
State/province [39]
0
0
Patras
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
GE
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
MI
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
TO
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
VR
Query!
Country [44]
0
0
Netherlands
Query!
State/province [44]
0
0
Amsterdam
Query!
Country [45]
0
0
Netherlands
Query!
State/province [45]
0
0
Heerlen
Query!
Country [46]
0
0
Netherlands
Query!
State/province [46]
0
0
Leiden
Query!
Country [47]
0
0
Netherlands
Query!
State/province [47]
0
0
Rotterdam
Query!
Country [48]
0
0
Norway
Query!
State/province [48]
0
0
Kongsvinger
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Bialystok
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Elblag
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Poznan
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Warszawa
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
Barnaul
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Kemerovo
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
S.-Petersburg
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Saint Petersburg
Query!
Country [57]
0
0
Russian Federation
Query!
State/province [57]
0
0
St-Petersburg
Query!
Country [58]
0
0
Slovakia
Query!
State/province [58]
0
0
SVK
Query!
Country [59]
0
0
Slovakia
Query!
State/province [59]
0
0
Partizanske
Query!
Country [60]
0
0
Slovakia
Query!
State/province [60]
0
0
Sabinov
Query!
Country [61]
0
0
Slovakia
Query!
State/province [61]
0
0
Stara Lubovna
Query!
Country [62]
0
0
Slovakia
Query!
State/province [62]
0
0
Topolcany
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Andalucia
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Barcelona
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Cantabria
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Galicia
Query!
Country [67]
0
0
Spain
Query!
State/province [67]
0
0
Vizcaya
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Madrid
Query!
Country [69]
0
0
Switzerland
Query!
State/province [69]
0
0
Fribourg
Query!
Country [70]
0
0
Switzerland
Query!
State/province [70]
0
0
St Gallen
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
London
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Doncaster
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFa therapy.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02159053
Query!
Trial related presentations / publications
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19. Dougados M, Kiltz U, Kivitz A, Pavelka K, Rohrer S, McCreddin S, Quebe-Fehling E, Porter B, Talloczy Z. Nonsteroidal anti-inflammatory drug-sparing effect of secukinumab in patients with radiographic axial spondyloarthritis: 4-year results from the MEASURE 2, 3 and 4 phase III trials. Rheumatol Int. 2022 Feb;42(2):205-213. doi: 10.1007/s00296-021-05044-6. Epub 2021 Nov 13. van der Horst-Bruinsma I, Miceli-Richard C, Braun J, Marzo-Ortega H, Pavelka K, Kivitz AJ, Deodhar A, Bao W, Porter B, Pournara E. A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis. Rheumatol Ther. 2021 Dec;8(4):1775-1787. doi: 10.1007/s40744-021-00380-2. Epub 2021 Oct 7. Schett G, Baraliakos X, Van den Bosch F, Deodhar A, Ostergaard M, Gupta AD, Mpofu S, Fox T, Winseck A, Porter B, Shete A, Gensler LS. Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies. J Rheumatol. 2021 Aug;48(8):1251-1258. doi: 10.3899/jrheum.201111. Epub 2021 Mar 15. Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15. Kivitz AJ, Wagner U, Dokoupilova E, Supronik J, Martin R, Talloczy Z, Richards HB, Porter B. Efficacy and Safety of Secukinumab 150 mg with and Without Loading Regimen in Ankylosing Spondylitis: 104-week Results from MEASURE 4 Study. Rheumatol Ther. 2018 Dec;5(2):447-462. doi: 10.1007/s40744-018-0123-5. Epub 2018 Aug 18.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
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
Query!
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