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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005575-41 | EudraCT Number |
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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-TNFα therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab 150 mg s.c. with loading | Experimental | Secukinumab 150 mg at Baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4. |
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| Secukinumab 150 mg s.c. without loading | Experimental | Secukinumab 150 mg at Baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2, and 3. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Biological | Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks | 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) | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Responded for ASAS 40 Response at 16 Weeks | 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:
|
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Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anniston | Alabama | 36207-5710 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41965705 | Derived | 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. | |
| 35305260 | Derived | 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. |
| Label | URL |
|---|---|
| Introduction to clinical trials conducted by Novartis and to results of completed studies, with the aim of increasing the transparency of Novartis clinical research and making publicly available objective scientific information in a standardised format. | View source |
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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
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A total of 424 participants were screened, out of which 350 participants completed the screening phase and were randomized to three treatment groups in 1:1:1 ratio.
The study was conducted at 85 centers in 19 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab 150 mg With Loading Dose | Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4. |
| FG001 | Secukinumab 150 mg Without Loading Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Secukinumab | Biological | Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio |
|
|
| Placebo | Biological | Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio |
|
| 16 Weeks |
| Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks | 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. | Baseline, 16 Weeks |
| Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks | 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:
| 16 Weeks |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks | 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:
| Baseline, 16 Weeks |
| Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36) | 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. | Baseline, 16 Weeks |
| Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks | 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). | Baseline, 16 Weeks |
| Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks | 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. | 104 Weeks |
| Percentage of Participants Responded for ASAS 20 at Week 4 | 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:
| Week 4 |
| Percentage of Participants Responded for ASAS 40 Response at Week 4 | 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:
| Week 4 |
| Upland |
| California |
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| United States |
| Novartis Investigative Site | Aventura | Florida | 33180 | United States |
| Novartis Investigative Site | Peoria | Illinois | 61602 | United States |
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| Novartis Investigative Site | Oklahoma City | Oklahoma | 73103 | United States |
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| Novartis Investigative Site | Seattle | Washington | 98101 | United States |
| Novartis Investigative Site | Kogarah | New South Wales | 2217 | Australia |
| Novartis Investigative Site | Maroochydore | Queensland | 4558 | Australia |
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| Novartis Investigative Site | Winnipeg | Manitoba | R3A 1M1 | Canada |
| Novartis Investigative Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Novartis Investigative Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Novartis Investigative Site | Ostrava | Czech Republic | 772 00 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 128 50 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 148 00 | Czechia |
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| Novartis Investigative Site | Hyvinkää | 05800 | Finland |
| Novartis Investigative Site | Jyväskylä | FIN-40620 | Finland |
| Novartis Investigative Site | Göttingen | Lower Saxony | 37075 | Germany |
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| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Magdeburg | 39110 | Germany |
| Novartis Investigative Site | München | 81541 | Germany |
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| Novartis Investigative Site | Athens | 12462 | Greece |
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| Novartis Investigative Site | Amsterdam | 1105 AZ | Netherlands |
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| Novartis Investigative Site | Piešťany | SVK | 921 12 | Slovakia |
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| Novartis Investigative Site | Sabinov | 08301 | Slovakia |
| Novartis Investigative Site | Stará Ľubovňa | 06401 | Slovakia |
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| Novartis Investigative Site | Córdoba | Andalusia | 14004 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| Novartis Investigative Site | Leytonstone | London | E11 1NR | United Kingdom |
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| 34773130 | Derived | 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. |
| 34618347 | Derived | 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. |
| 33722947 | Derived | 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. |
| 31203228 | Derived | 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. |
| 30121827 | Derived | 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. |
Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3. |
| FG002 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
| Paticipants Week 16 Onwards |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab 150 mg With Loading Dose | Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4. |
| BG001 | Secukinumab 150 mg Without Loading Dose | Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3. |
| BG002 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Patient's global assessment of disease activity | The patient's global assessment of disease activity was performed using a 0-100 millimeter (mm) VAS ranging from not severe to very severe, after the question, "How active was your disease on average during the last week?" | Mean | Standard Deviation | units on a scale |
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| Total back pain (0-100 mm) | Total back pain as measured by VAS ≥ 40 mm on a scale of 0-100 mm. | Mean | Standard Deviation | units on a scale |
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| BASDAI | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consisted of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which was used to answer 6 questions pertaining to the 5 major symptoms of Ankylosing Spondylitis: 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. | Mean | Standard Deviation | units on a scale |
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| hs C-reactive protein | High sensitivity C-reactive protein assessment was performed in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. | Mean | Standard Deviation | Milligrams per Litre (mg/L) |
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| 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 | Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks | 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) | The analysis was performed in Full analysis set (FAS) population, defined as all participants who were randomized and received study treatment. Here, "Number of participants analysed" signifies participants evaluable for ASAS20 at Week 16. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Responded for ASAS 40 Response at 16 Weeks | 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:
| The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASAS 40 response at Week 16. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 Weeks |
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| Secondary | Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks | 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. | The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for hsCRP at Week 16. | Posted | Mean | Standard Deviation | Ratio | Baseline, 16 Weeks |
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| Secondary | Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks | 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:
| The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASAS 5/6 response at Week 16. | Posted | Number | 95% Confidence Interval | percentage of participants | 16 Weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks | 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:
| The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for BASDAI at Week 16. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36) | 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. | The analysis was performed in FAS population.Here, "Number of participants analysed" signifies participants evaluable for PCS of the SF-36 at Week 16. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks | 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). | The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASQoL at Week 16. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 Weeks |
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| Secondary | Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks | 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. | The analysis was performed on the safety population, defined as all participants who took at least one dose of study treatment during the treatment period. | Posted | Number | participants | 104 Weeks |
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| Secondary | Percentage of Participants Responded for ASAS 20 at Week 4 | 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:
| The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASAS 20 at Week 16. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Responded for ASAS 40 Response at Week 4 | 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:
| The analysis was performed in FAS population. Here, "Number of participants analysed" signifies participants evaluable for ASAS 40 response at Week 16. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 104 weeks.
Serious Adverse Events are monitored from date of First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV). All other adverse events are monitored from First Participant First Treatment until LPLV.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab 150 mg Without Loading Dose | Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3. | 2 | 116 | 18 | 116 | 90 | 116 |
| EG001 | Secukinumab 150 mg With Loading | Participants were s.c. administered with 150 mg of secukinumab at baseline, Weeks 1, 2, and 3, followed by dosing every four weeks starting at Week 4. | 0 | 117 | 11 | 117 | 89 | 117 |
| EG002 | All Secukinumab 150 mg Treated Participants | All participants who were s.c. administered with secukinumab during the study. | 4 | 346 | 43 | 346 | 254 | 346 |
| EG003 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. | 0 | 117 | 4 | 117 | 54 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute vestibular syndrome | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Femoroacetabular impingement | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Testis cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Somatic symptom disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bladder diverticulum | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 8627788300 |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
|
|
|
|
Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3. |
| OG002 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
|
|
Participants were s.c. administered with 150 mg of secukinumab at baseline, followed by dosing every four weeks starting at Week 4, and with Placebo at Weeks 1, 2, and 3. |
| OG002 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
|
|
| OG002 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
|
|
| OG002 |
| Placebo |
Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
|
|
| OG002 |
| Placebo |
Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
| OG003 | All Secukinumab 150 mg Treated Participants | All participants who were s.c. administered with secukinumab during the study. |
|
|
| OG002 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
|
|
| OG002 | Placebo | Participants were s.c. administered with placebo matching to secukinumab at baseline, Weeks 1, 2, 3, 4, 8, and 12. Participants were further administered with 150 mg of secukinumab every four weeks starting at Week 16. |
|
|