Back to resultsStudy of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, secukinumab, AIN457H, SpondyloArthritis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS with active AS assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI question #2) at Baseline
- Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications
- Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or have been intolerant to at least one administration of an anti-TNFα agent
Exclusion Criteria:
- Patients with total ankylosis of the spine
- Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
- Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis
- Known infection with HIV, hepatitis B or hepatitis C at screening or baseline
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
secukinumab 150mg
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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.
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.
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)
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
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.
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.
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.
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.
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
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02750592
Brief Title
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Official Title
An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 22, 2016 (Actual)
Primary Completion Date
July 5, 2017 (Actual)
Study Completion Date
May 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis, secukinumab, AIN457H, SpondyloArthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
secukinumab 150mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.
Intervention Description
Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.
Primary Outcome Measure Information:
Title
Assessment of SpondyloArthritis International Society 20 Response (ASAS20)
Description
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
Time Frame
week 16
Secondary Outcome Measure Information:
Title
ASAS 40 Response Rate With Non-responder Imputation (NRI)
Description
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
Time Frame
Week 16
Title
Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate
Description
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
Time Frame
Week 16
Title
Change in High Sensitivity C-Reactive Protein (hsCRP)
Description
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
Time Frame
baseline, Week 16
Title
Number of Participants With ASAS 5/6 Response Criteria
Description
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
Time Frame
Week 16
Title
Mean Change From Baseline in BASDAI From Baseline
Description
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.
Time Frame
Baseline, week 16
Title
Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score
Description
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.
Time Frame
Baseline, week 16
Title
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
Description
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)
Time Frame
Baseline, week 16
Title
Proportion of Participants Achieving ASAS Partial Remission
Description
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
Time Frame
week 16
Title
Change in Serum Concentration of Secukinumab
Description
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.
Time Frame
Baseline, weeks 4, 16, 24, 52, 60
Title
Number of Participants With Immunogenicity Against Secukinumab
Description
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.
Time Frame
week 60
Title
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Description
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.
Time Frame
week 60
Title
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Description
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.
Time Frame
week 60
Title
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
Description
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
Time Frame
week 60
Title
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
Description
During the entire safety reporting period, mean values of each lipid parameter stayed within the normal range and were comparable to the baseline values
Time Frame
week 60
Title
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Description
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)
Time Frame
week 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS with active AS assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI question #2) at Baseline
Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications
Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or have been intolerant to at least one administration of an anti-TNFα agent
Exclusion Criteria:
Patients with total ankylosis of the spine
Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis
Known infection with HIV, hepatitis B or hepatitis C at screening or baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Kitakyushu-city
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Novartis Investigative Site
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Novartis Investigative Site
City
Nankoku city
State/Province
Kochi
ZIP/Postal Code
783 8505
Country
Japan
Facility Name
Novartis Investigative Site
City
Tenri
State/Province
Nara
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
Novartis Investigative Site
City
Okayama-city
State/Province
Okayama
ZIP/Postal Code
700-0013
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawachinagano
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Novartis Investigative Site
City
Suita city
State/Province
Osaka
ZIP/Postal Code
565 0871
Country
Japan
Facility Name
Novartis Investigative Site
City
Bunkyo ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Novartis Investigative Site
City
Chuo ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0054
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
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
Learn more about this trial
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
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