16 Week Efficacy and 2 Year Long Term Safety and Efficacy... | NCT01358175 | Trialant
NCT01358175
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Mar 9, 2017Actual
Enrollment
371Actual
Phase
Phase 3
Conditions
Ankylosing Spondylitis
Interventions
Secukinumab (75 mg)
Secukinumab (150 mg)
Placebo
Countries
United States
Belgium
Bulgaria
Canada
France
Germany
Italy
Mexico
Netherlands
Peru
Russia
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01358175
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457F2305
Secondary IDs
ID
Type
Description
Link
2010-024529-18
EudraCT Number
Brief Title
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
Acronym
MEASURE 1
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jan 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2011
Primary Completion Date
Dec 2014Actual
Completion Date
Dec 2014Actual
First Submitted Date
May 19, 2011
First Submission Date that Met QC Criteria
May 20, 2011
First Posted Date
May 23, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 14, 2015
Results First Submitted that Met QC Criteria
Dec 1, 2016
Results First Posted Date
Jan 27, 2017Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 27, 2017
Last Update Posted Date
Mar 9, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
Detailed Description
Not provided
Conditions Module
Conditions
Ankylosing Spondylitis
Keywords
Ankylosing spondylitis
AS
ASAS
inflammatory back pain
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
371Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Experimental
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Drug: Secukinumab (75 mg)
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Experimental
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Drug: Secukinumab (150 mg)
Placebo
Placebo Comparator
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Secukinumab (75 mg)
Drug
Secukinumab (75 mg)
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.
16 weeks
Secondary Outcomes
Measure
Description
Time Frame
Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Male or non-pregnant, non-lactating female patients at least 18 years of age
Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
Patients should have been on NSAIDs with an inadequate response
Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response
Exclusion criteria:
Chest X-ray with evidence of ongoing infectious or malignant process
Patients with total ankylosis of the spine
Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
Previous treatment with any cell-depleting therapies
Other protocol-defined inclusion/exclusion criteria may apply
Ramiro S, Gaillez C, Kiltz U, Gensler LS, Pisal C, Braun J, Ogdie A. No major effect of age (< 40 vs. >/= 40 years) on response to secukinumab in patients with axSpA: a post hoc analysis of six phase 3 trials. Arthritis Res Ther. 2026 Apr 11;28(1):112. doi: 10.1186/s13075-026-03804-y.
Jamaludin A, Windsor R, Ather S, Kadir T, Zisserman A, Braun J, Gensler LS, Ostergaard M, Poddubnyy D, Coroller T, Porter B, Ligozio G, Readie A, Machado PM. Automated detection of spinal bone marrow oedema in axial spondyloarthritis: training and validation using two large phase 3 trial datasets. Rheumatology (Oxford). 2025 Oct 1;64(10):5446-5454. doi: 10.1093/rheumatology/keaf323.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.
Base line and Week 16
Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response
ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.
16 weeks
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis.
Baseline and 16 weeks
Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS
SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
baseline, 16 weeks
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL
ASQoL is an 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 participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.
baseline and 16 weeks
Assessment of Responders for ASAS Partial Remission
ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.
Braun J, Buehring B, Baraliakos X, Gensler LS, Porter B, Quebe-Fehling E, Haemmerle S. Effects of secukinumab on bone mineral density and bone turnover biomarkers in patients with ankylosing spondylitis: 2-year data from a phase 3 study, MEASURE 1. BMC Musculoskelet Disord. 2021 Dec 13;22(1):1037. doi: 10.1186/s12891-021-04930-1.
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.
Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.
Himmler S, Branner JC, Ostwald DA. The societal impact of a biologic treatment of ankylosing spondylitis: a case study based on secukinumab. J Comp Eff Res. 2021 Feb;10(2):143-155. doi: 10.2217/cer-2020-0077. Epub 2020 Nov 30.
Kvien TK, Conaghan PG, Gossec L, Strand V, Ostergaard M, Poddubnyy D, Williams N, Porter B, Shete A, Gilloteau I, Deodhar A. Secukinumab and Sustained Reduction in Fatigue in Patients With Ankylosing Spondylitis: Long-Term Results of Two Phase III Randomized Controlled Trials. Arthritis Care Res (Hoboken). 2022 May;74(5):759-767. doi: 10.1002/acr.24517. Epub 2022 Mar 10.
Deodhar AA, Miceli-Richard C, Baraliakos X, Marzo-Ortega H, Gladman DD, Blanco R, Das Gupta A, Martin R, Safi J Jr, Porter B, Shete A, Rosenbaum JT. Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR Open Rheumatol. 2020 May;2(5):294-299. doi: 10.1002/acr2.11139. Epub 2020 Apr 30.
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.
Braun J, Deodhar A, Landewe R, Baraliakos X, Miceli-Richard C, Sieper J, Quebe-Fehling E, Martin R, Porter B, Gandhi KK, van der Heijde D; MEASURE 1 and MEASURE 2 study groups. Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies. RMD Open. 2018 Nov 21;4(2):e000749. doi: 10.1136/rmdopen-2018-000749. eCollection 2018.
Wei JC, Baeten D, Sieper J, Deodhar A, Bhosekar V, Martin R, Porter B. Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies. Int J Rheum Dis. 2017 May;20(5):589-596. doi: 10.1111/1756-185X.13094. Epub 2017 May 25.
Braun J, Baraliakos X, Deodhar A, Baeten D, Sieper J, Emery P, Readie A, Martin R, Mpofu S, Richards HB; MEASURE 1 study group. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study. Ann Rheum Dis. 2017 Jun;76(6):1070-1077. doi: 10.1136/annrheumdis-2016-209730. Epub 2016 Dec 13.
Deodhar AA, Dougados M, Baeten DL, Cheng-Chung Wei J, Geusens P, Readie A, Richards HB, Martin R, Porter B. Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1). Arthritis Rheumatol. 2016 Dec;68(12):2901-2910. doi: 10.1002/art.39805.
Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, Deodhar A, Porter B, Martin R, Andersson M, Mpofu S, Richards HB; MEASURE 1 Study Group; MEASURE 2 Study Group. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. N Engl J Med. 2015 Dec 24;373(26):2534-48. doi: 10.1056/NEJMoa1505066.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
FG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
FG000124 subjects
FG001125 subjects
FG002122 subjects
COMPLETED
FG000103 subjects
FG00197 subjects
FG00290 subjects
NOT COMPLETED
FG00021 subjects
FG00128 subjects
FG00232 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0021 subjects
Withdrawal by Subject
FG0009 subjects
FG0015 subjects
FG00210 subjects
Technical issues
FG0000 subjects
FG0011 subjects
FG0020 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
Non Compliance with Study Treatment
FG0000 subjects
FG0011 subjects
FG0021 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0023 subjects
Lack of Efficacy
FG0003 subjects
FG0018 subjects
FG0026 subjects
Adverse Event
FG0006 subjects
FG00111 subjects
FG00211 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
BG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
BG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000124
BG001125
BG002122
BG003371
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00036
BG00141
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.
FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.
Posted
Number
% responders
16 weeks
ID
Title
Description
OG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Units
Counts
Participants
OG000124
OG001125
OG002122
Title
Denominators
Categories
Title
Measurements
OG00059.7
OG00160.8
OG00228.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Regression, Logistic
<0.0001
Odds Ratio (OR)
3.76
2-Sided
95
2.20
6.42
Superiority or Other
OG001
OG002
Regression, Logistic
<0.0001
Secondary
Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.
FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.
Posted
Number
% responders
16 weeks
ID
Title
Description
OG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Secondary
Change From Baseline in Serum hsCRP
The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.
FAS. Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value are from mixed-effect model repeated measures (MMRM) with treatment, visit, TNF-alpha inhibitor status as factors, log(e) baseline and weight as covariates.
Posted
Least Squares Mean
Standard Error
ratio
Base line and Week 16
ID
Title
Description
OG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Secondary
Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response
ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Posted
Number
% responders
16 weeks
ID
Title
Description
OG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis.
Posted
Least Squares Mean
Standard Error
units on scale
Baseline and 16 weeks
ID
Title
Description
OG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Secondary
Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS
SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Posted
Least Squares Mean
Standard Error
units on a scale
baseline, 16 weeks
ID
Title
Description
OG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
Secondary
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL
ASQoL is an 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 participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.
Posted
Least Squares Mean
Standard Error
units on a scale
baseline and 16 weeks
ID
Title
Description
OG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Secondary
Assessment of Responders for ASAS Partial Remission
ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.
Posted
Number
% responders
16 weeks
ID
Title
Description
OG000
Secukinumab 10 mg/kg i.v. / 75 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG001
Secukinumab 10 mg/kg i.v. / 150 mg s.c.
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
OG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Time Frame
Baseline to week 104
Description
Patients initially randomized to placebo were assessed for ASAS 20 response at Week 16 and switched to active treatment at Week 16 (for placebo non-responders) or at Week 24 (for placebo responders). Blinding was maintained beyond the primary endpoint to ensure reliable efficacy and safety measures
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Secukinumab 10mg/kg -75 mg
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
16
124
88
124
EG001
Secukinumab 10mg/kg -150 mg
Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
13
125
100
125
EG002
Placebo Secukinumab
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 up to end of Study
5
122
52
122
EG003
Placebo Non-Resp Secukinumab 75 mg
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 75 mg
5
39
24
39
EG004
Placebo Non-Resp Secukinumab 150 mg
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 150 mg
8
38
27
38
EG005
Placebo Resp Secukinumab 75 mg
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 75 mg
3
17
12
17
EG006
Placebo Resp Secukinumab 150 mg
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 150 mg
1
18
13
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal lymphadenopathy
Blood and lymphatic system disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG0030 affected39 at risk
EG004
Anaemia
Blood and lymphatic system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Cataract
Eye disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Uveitis
Eye disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Lumbar hernia
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Application site pain
General disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Chest discomfort
General disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Pyrexia
General disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Hepatitis toxic
Hepatobiliary disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Hepatosplenomegaly
Hepatobiliary disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Helicobacter gastritis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Dislocation of vertebra
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Postoperative thrombosis
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Ankylosing spondylitis
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Vocal cord paresis
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Abortion incomplete
Pregnancy, puerperium and perinatal conditions
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Depression
Psychiatric disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Varicose vein
Vascular disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA (18.0)
Systematic Assessment
EG00010 affected124 at risk
EG0018 affected125 at risk
EG0021 affected122 at risk
EG0031 affected39 at risk
EG0040 affected38 at risk
EG0051 affected17 at risk
EG0060 affected18 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (18.0)
Systematic Assessment
EG0004 affected124 at risk
EG0013 affected125 at risk
EG0020 affected122 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0012 affected125 at risk
EG0021 affected122 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Iritis
Eye disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0021 affected122 at risk
EG003
Uveitis
Eye disorders
MedDRA (18.0)
Systematic Assessment
EG0004 affected124 at risk
EG0014 affected125 at risk
EG0022 affected122 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0018 affected125 at risk
EG0020 affected122 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0009 affected124 at risk
EG0017 affected125 at risk
EG0020 affected122 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0013 affected125 at risk
EG0021 affected122 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0012 affected125 at risk
EG0021 affected122 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG00016 affected124 at risk
EG00121 affected125 at risk
EG0027 affected122 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0021 affected122 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0008 affected124 at risk
EG0015 affected125 at risk
EG0023 affected122 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0007 affected124 at risk
EG0018 affected125 at risk
EG0022 affected122 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0013 affected125 at risk
EG0020 affected122 at risk
EG003
Fatigue
General disorders
MedDRA (18.0)
Systematic Assessment
EG0005 affected124 at risk
EG0013 affected125 at risk
EG0022 affected122 at risk
EG003
Pyrexia
General disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0022 affected122 at risk
EG003
VARICELLA ZOSTER VIRUS INFECTION
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Acute tonsillitis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0016 affected125 at risk
EG0022 affected122 at risk
EG003
Infection parasitic
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Influenza
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0007 affected124 at risk
EG00112 affected125 at risk
EG0022 affected122 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG00025 affected124 at risk
EG00134 affected125 at risk
EG0029 affected122 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0016 affected125 at risk
EG0020 affected122 at risk
EG003
Paronychia
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG00010 affected124 at risk
EG00118 affected125 at risk
EG0021 affected122 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0004 affected124 at risk
EG0018 affected125 at risk
EG0020 affected122 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0004 affected124 at risk
EG0015 affected125 at risk
EG0023 affected122 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG00017 affected124 at risk
EG0019 affected125 at risk
EG0022 affected122 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0017 affected125 at risk
EG0020 affected122 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0004 affected124 at risk
EG0013 affected125 at risk
EG0020 affected122 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0015 affected125 at risk
EG0020 affected122 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0021 affected122 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0011 affected125 at risk
EG0021 affected122 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0013 affected125 at risk
EG0021 affected122 at risk
EG003
Osteoprotegerin decreased
Investigations
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0014 affected125 at risk
EG0022 affected122 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA (18.0)
Systematic Assessment
EG00015 affected124 at risk
EG00113 affected125 at risk
EG0026 affected122 at risk
EG003
Ankylosing spondylitis
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0016 affected125 at risk
EG0024 affected122 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0008 affected124 at risk
EG00111 affected125 at risk
EG0024 affected122 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0006 affected124 at risk
EG00111 affected125 at risk
EG0020 affected122 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0013 affected125 at risk
EG0021 affected122 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0014 affected125 at risk
EG0022 affected122 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0004 affected124 at risk
EG0011 affected125 at risk
EG0022 affected122 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0005 affected124 at risk
EG0016 affected125 at risk
EG0024 affected122 at risk
EG003
Headache
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG00018 affected124 at risk
EG00118 affected125 at risk
EG0027 affected122 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0015 affected125 at risk
EG0020 affected122 at risk
EG003
Tremor
Nervous system disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (18.0)
Systematic Assessment
EG0003 affected124 at risk
EG0014 affected125 at risk
EG0022 affected122 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0007 affected124 at risk
EG0017 affected125 at risk
EG0022 affected122 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG00010 affected124 at risk
EG00111 affected125 at risk
EG0026 affected122 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0015 affected125 at risk
EG0020 affected122 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0011 affected125 at risk
EG0020 affected122 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0021 affected122 at risk
EG003
Nail dystrophy
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0000 affected124 at risk
EG0010 affected125 at risk
EG0020 affected122 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0002 affected124 at risk
EG0016 affected125 at risk
EG0021 affected122 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0015 affected125 at risk
EG0020 affected122 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Systematic Assessment
EG0001 affected124 at risk
EG0012 affected125 at risk
EG0020 affected122 at risk
EG003
Hypertension
Vascular disorders
MedDRA (18.0)
Systematic Assessment
EG0006 affected124 at risk
EG0014 affected125 at risk
EG0020 affected122 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Disclosure Office
Novartis Pharmaceuticals
862-778-8300
ID
Term
D013167
Spondylitis, Ankylosing
Ancestor Terms
ID
Term
D000089183
Axial Spondyloarthritis
D025242
Spondylarthropathies
D025241
Spondylarthritis
D013166
Spondylitis
D013122
Spinal Diseases
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D000844
Ankylosis
D007592
Joint Diseases
D001168
Arthritis
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C555450
secukinumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0
Between 18 and 65 years
BG000117
BG001122
BG002115
BG003354
>=65 years
BG0007
BG0013
BG0027
BG00317
37
BG003114
Male
BG00088
BG00184
BG00285
BG003257
Odds Ratio (OR)
3.89
2-Sided
95
2.28
6.65
Superiority or Other
Units
Counts
Participants
OG000124
OG001125
OG002122
Title
Denominators
Categories
Title
Measurements
OG00033.1
OG00141.6
OG00213.1
Units
Counts
Participants
OG000124
OG001125
OG002122
Title
Denominators
Categories
Title
Measurements
OG0000.45± 1.092
OG0010.4± 1.090
OG0020.97± 1.095
Units
Counts
Participants
OG000124
OG001125
OG002122
Title
Denominators
Categories
Title
Measurements
OG00045.2
OG00148.8
OG00213.1
OG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
Units
Counts
Participants
OG000124
OG001125
OG002122
Title
Denominators
Categories
Title
Measurements
OG000-2.34± 0.175
OG001-2.32± 0.172
OG002-0.59± 0.180
OG002
Placebo
Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12