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The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| secukinumab 150mg | Experimental | A screening (SCR) epoch running 4-10 weeks before baseline (BSL) was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consist of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 follows a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinue prematurely. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection. | Drug | Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of SpondyloArthritis International Society 20 Response (ASAS20) | This table is ASAS20 response using non-responder imputation for FAS It assesses the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response. The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain | week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| ASAS 40 Response Rate With Non-responder Imputation (NRI) | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS 40 response ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain | Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Kitakyushu | Fukuoka | 807-8556 | Japan | ||
| Novartis Investigative Site |
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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Seven patients were screening failures
A total of 37 patients were screened, and 30 patients (81.1%) completed the screening phase and entered Treatment Period
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab 150mg | A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 26, 2015 | May 14, 2019 |
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| Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 response The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline | Week 16 |
| Change in High Sensitivity C-Reactive Protein (hsCRP) | hsCRP (mg/L) change from baseline using observed data with log e transformation The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline of high sensitivity C-Reactive Protein (hsCRP) hsCRP is measured as a marker of inflammation from blood samples during the study | baseline, Week 16 |
| Number of Participants With ASAS 5/6 Response Criteria | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients meeting the ASAS 5/6 response criteria The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains | Week 16 |
| Mean Change From Baseline in BASDAI From Baseline | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in total BASDAI The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS Each question (question 1 to 6) is scored from 0 to 10 (0 being no problem and 10 being the worst problem). To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. | Baseline, week 16 |
| Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score | SF-36 PCS, mean change from baseline: The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions Score range is from 0 (no problems) to 100 (unable to perform the activity) SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline. There is no total overall score; scoring is computed for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. | Baseline, week 16 |
| Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) The ASQoL is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity) | Baseline, week 16 |
| Proportion of Participants Achieving ASAS Partial Remission | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS partial remission The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10 | week 16 |
| Change in Serum Concentration of Secukinumab | The assessment of pre dose concentration of secukinumab in Japanese AS patients An enzyme-linked immunosorbent assay (ELISA) method will be used for bioanalytical analysis of secukinumab in serum, with an anticipated lower limit of quantification (LLOQ) of 80 ng/mL. | Baseline, weeks 4, 16, 24, 52, 60 |
| Number of Participants With Immunogenicity Against Secukinumab | Concentration of anti-secukinumab antibodies Assessment of immunogenicity against secukinumab by concentration of anti-secukinumab antibodies at pre-dose. An electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation. | week 60 |
| Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood | Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-5 refer to severity of the AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. *Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. **Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. | week 60 |
| Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade | Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-5 refer to severity of the AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. *Instrumental ADL include preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. **Self care ADL include bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. | week 60 |
| Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities | During the entire safety reporting period, mean values of each liver enzyme parameter stayed within the normal range and were comparable to the baseline values ALP=Alkaline phosphatase ALT=Alanine aminotransferase AST=Aspartate aminotransferase TBL=Total bilirubin ULN=Upper Limit Normal | week 60 |
| Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities | During the entire safety reporting period, mean values of each lipid parameter stayed within the normal range and were comparable to the baseline values | week 60 |
| Participants With Newly Occurring Notable Abnormalities in Vital Signs | Sitting Pulse (bpm) High only (> 100 bpm) Low only (< 60 bpm) Low and High (< 60 bpm and > 100 bpm) Sitting Diastolic Blood Pressure (BP) (mmHg) High only (≥ 90 mmHg) Low only (< 60 mmHg) Low and High (< 60 mmHg and ≥ 90 mmHg) Sitting Systolic Blood Pressure (mmHg) High only (≥ 140 mmHg) Low only (< 90 mmHg) Low and High (< 90 mmHg and ≥ 140 mmHg) | week 60 |
| Kita-gun |
| Kagawa-ken |
| 761-0793 |
| Japan |
| Novartis Investigative Site | Nankoku | Kochi | 783 8505 | Japan |
| Novartis Investigative Site | Tenri | Nara | 632-8552 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 700-0013 | Japan |
| Novartis Investigative Site | Kawachi-Nagano | Osaka | 586-8521 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565 0871 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104-8560 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 160-0054 | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety set included all patients who took at least one dose of study treatment during the treatment periods.
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab 150mg | A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 SpondyloArthritis International Society 20 Response (ASAS20) | This table is ASAS20 response using non-responder imputation for FAS It assesses the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response. The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain | Full analysis set (FAS): The FAS comprised of all patients who entered into the treatment periods. | Posted | Number | participants | week 16 |
|
|
| ||||||||||||||||||||||||||
| Secondary | ASAS 40 Response Rate With Non-responder Imputation (NRI) | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS 40 response ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain | FAS | Posted | Number | participants | Week 16 |
|
| |||||||||||||||||||||||||||
| Secondary | Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 response The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline | FAS | Posted | Number | participants | Week 16 |
|
| |||||||||||||||||||||||||||
| Secondary | Change in High Sensitivity C-Reactive Protein (hsCRP) | hsCRP (mg/L) change from baseline using observed data with log e transformation The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline of high sensitivity C-Reactive Protein (hsCRP) hsCRP is measured as a marker of inflammation from blood samples during the study | FAS | Posted | Geometric Mean | 95% Confidence Interval | mg/L | baseline, Week 16 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With ASAS 5/6 Response Criteria | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients meeting the ASAS 5/6 response criteria The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains | FAS | Posted | Number | participants | Week 16 |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in BASDAI From Baseline | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in total BASDAI The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS Each question (question 1 to 6) is scored from 0 to 10 (0 being no problem and 10 being the worst problem). To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline, week 16 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score | SF-36 PCS, mean change from baseline: The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions Score range is from 0 (no problems) to 100 (unable to perform the activity) SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline. There is no total overall score; scoring is computed for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline, week 16 |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) The ASQoL is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity) | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline, week 16 |
|
| ||||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving ASAS Partial Remission | The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS partial remission The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10 | FAS | Posted | Number | participants | week 16 |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Serum Concentration of Secukinumab | The assessment of pre dose concentration of secukinumab in Japanese AS patients An enzyme-linked immunosorbent assay (ELISA) method will be used for bioanalytical analysis of secukinumab in serum, with an anticipated lower limit of quantification (LLOQ) of 80 ng/mL. | FAS | Posted | Mean | Standard Deviation | μg/mL | Baseline, weeks 4, 16, 24, 52, 60 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Immunogenicity Against Secukinumab | Concentration of anti-secukinumab antibodies Assessment of immunogenicity against secukinumab by concentration of anti-secukinumab antibodies at pre-dose. An electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation. | The safety set included all patients who took at least one dose of study treatment during the treatment periods. | Posted | Number | participants | week 60 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood | Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-5 refer to severity of the AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. *Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. **Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. | The safety set included all patients who took at least one dose of study treatment during the treatment periods. | Posted | Number | participants | week 60 |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade | Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-5 refer to severity of the AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. *Instrumental ADL include preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. **Self care ADL include bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. | safety set | Posted | Number | participants | week 60 |
| ||||||||||||||||||||||||||||
| Secondary | Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities | During the entire safety reporting period, mean values of each liver enzyme parameter stayed within the normal range and were comparable to the baseline values ALP=Alkaline phosphatase ALT=Alanine aminotransferase AST=Aspartate aminotransferase TBL=Total bilirubin ULN=Upper Limit Normal | safety set | Posted | Number | participants | week 60 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities | During the entire safety reporting period, mean values of each lipid parameter stayed within the normal range and were comparable to the baseline values | safety set | Posted | Number | participants | week 60 |
|
| |||||||||||||||||||||||||||
| Secondary | Participants With Newly Occurring Notable Abnormalities in Vital Signs | Sitting Pulse (bpm) High only (> 100 bpm) Low only (< 60 bpm) Low and High (< 60 bpm and > 100 bpm) Sitting Diastolic Blood Pressure (BP) (mmHg) High only (≥ 90 mmHg) Low only (< 60 mmHg) Low and High (< 60 mmHg and ≥ 90 mmHg) Sitting Systolic Blood Pressure (mmHg) High only (≥ 140 mmHg) Low only (< 90 mmHg) Low and High (< 90 mmHg and ≥ 140 mmHg) | safety set | Posted | Number | participants | week 60 |
|
|
AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
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 | AIN457 150mg | A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely. | 0 | 30 | 3 | 30 | 26 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery occlusion | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
This single arm study has no comparator and therefore no statistical test for comparison was planned for the outcome measures
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 | 1-888-669-6682 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2018 | May 14, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| 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 |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
| >=75 years |
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| Units | Counts |
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| Participants |
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