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AScalate: Treat-to-target in Axial Spondyloarthritis (AScalate)

Primary Purpose

Axial Spondyloarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Secukinumab/Adalimumab-Biosimilar
Standard-of-care
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring axial spondyloarthritis, axSpA, treat-to-target, T2T, secukinumab, AIN457, Non-Radiographic Axial Spondyloarthritis, nr-axSpA, Radiographic Axial Spondyloarthritis, r-axSpA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Axial Spondyloarthritis, axSpA (either Non-Radiographic Axial Spondyloarthritis or Radiographic Axial Spondyloarthritis) fulfilling the Ankylosing Spondyloarthritis International Society classification criteria for axSpA
  • Active disease as defined by having an Ankylosing Spondylitis Disease Activity Score ≥ 2.1 at Screening and Baseline despite concurrent Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy, or intolerance/contraindication to NSAIDs.
  • Objective signs of inflammation at Screening as defined by: Magnetic Resonance Imaging (MRI) of sacroiliac joints performed up to 3 months prior to screening showing acute inflammatory lesion(s), OR elevated quick C-reactive Protein (CRP) (> 5 mg/L), OR MRI showing acute inflammatory lesion(s) in the sacroiliac joints and spine performed during screening period.
  • Inadequate response to NSAIDs

Exclusion Criteria:

  • Previous exposure to secukinumab or other biologic drug directly targeting Interleukin(IL)-17 or IL-17 receptor.
  • Patients who have previously been treated with Tumor Necrosis Factor Alpha inhibitors (investigational or approved).
  • Patients treated with any cell-depleting therapies.
  • Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunosuppressed the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy.
  • History of clinically significant liver disease or liver injury
  • History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum creatinine level exceeding 1.8 mg/dL (159.12 μmol/L).
  • Active systemic infections during the last 2 weeks (exception: common cold) prior to randomization.
  • History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis (TB) infection
  • Patients positive for human immunodeficiency virus, hepatitis B or hepatitis C
  • Life vaccinations within 6 weeks prior to Baseline or planned vaccination during study participation until 12 weeks after last study treatment administration.

Other protocol-defined inclusion/exclusion criteria may apply.

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
  • 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
  • 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
  • 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
  • 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 2

Arm Type

Experimental

Active Comparator

Arm Label

TREAT-TO-TARGET (T2T)

Standard-of-care (SOC)

Arm Description

Participants received secukinumab at a dose of 150 milligrams (mg) as subcutaneous (s.c.) injection at 150 mg dose at Baseline, Week 1, 2, 3, 4 and 8. From Week 12, only responders continued to receive 4-weekly doses until Week 32 if they maintained the response. In the event these patients experienced a loss of response from week 24 they were escalated to secukinumab 300 mg s.c. every 4 weeks until Week 32. Patients who were non-responders at Week 12 will received 4-weekly secukinumab 300 mg s.c. until Week 24. From Week 24, only responders continued to receive 4-weekly secukinumab 300 mg s.c. until Week 32. Patients who are non-responders to secukinumab 300 mg at Week 24 receive biweekly of adalimumab biosimilar 40 mg s.c. until Week 34

SOC treatment up to the maximum recommended dose at the discretion of the investigator as according to current recommendation for treatment of axSpA

Outcomes

Primary Outcome Measures

Percentage of patients achieving an Assessment of responders for the SpondyloArthritis International Society (ASAS) 40 response
The ASAS response measures consist of the following Domains: Patient's global assessment of disease activity measured on a visual analog scale (VAS). Patient's assessment of back pain, represented by either total or nocturnal pain scores, both measured on a VAS scale. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by VAS. Inflammation represented by mean duration and severity of morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) as measured by VAS scale. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment C-Reactive Protein (CRP) ASAS40 response is defined as an improvement of ≥ 40% and ≥ 2 units on a scale of 10 in at least 3 of the 4 domains and no worsening at all in the remaining domain.

Secondary Outcome Measures

Percentage of patients achieving an ASAS40 response
ASAS40 response is defined as an improvement of ≥ 40% and ≥ 2 units on a scale of 10 in at least 3 of the 4 domains and no worsening at all in the remaining domain.
Percentage of patients achieving ASAS20, ASAS partial response
ASAS20 response is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 0 to 10 in at least 3 of the 4 domains, and no worsening at all in the remaining domain. ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10.
The proportion of patients meeting the Ankylosing Spondylitis Disease Activity Score (ASDAS) definition of inactive disease, ASDAS clinically important and major improvement and ASDAS low disease activity
Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were < 1.3 between inactive disease and low disease activity, < 2.1 between low disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement".
The proportion of patients achieving the Bath Ankylosing Spondylitis Disease Activity Index response 50% (BASDAI 50) at Week 12 and Week 24
The BASDAI consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of the disease
The between-treatment difference in change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS. The 10 questions were chosen with major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the patients' ability to cope with everyday life. A 0 through 10 scale (captured as a continuous VAS) is used to answer the questions. The mean of the 10 scales gives the BASFI score - a value between 0 and 10.
The between-treatment difference in change from Baseline in Bath ankylosing spondylitis metrology index (BASMI) and chest expansion
The BASMI is a validated instrument that uses the minimum number of clinically appropriate measurements that accurately assess axial status, with the goal to define clinically significant changes in spinal movement. Parameters include: Lateral spinal flexion Tragus-to-wall distance Lumbar flexion (modified Schoeber) Maximal intermalleolar distance Cervical rotation angle Additionally, the following assessments should be taken: Chest expansion Occiput-to-wall distance
Change from baseline in the ASQoL (Ankylosing Spondylitis Quality of Life instrument)
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). As such, lower scores indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the questionnaire requires approximately 6 minutes to complete. The purpose of the ASQoL is to assess the disease specific QoL of patients in this study.
The between-treatment difference in change from baseline in ASAS-HI (Ankylosing Spondyloarthritis International Society Health Index)
The ASAS-HI is a disease-specific questionnaire that was developed based on the comprehensive International Classification of Functioning, Disability and Health Core Set (also known as the ICF Core Set) for AS. The ASAS HI is a linear composite measure and contains 17 items (dichotomous response option: "I agree" and "I do not agree"), which cover most of the ICF Core Set. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self-care, and community life. The total sum of the ASAS HI ranges from 0 to 17, with a lower score indicating a better health status. In addition, the Environmental Factor (EF) Item Set contains items addressing categories of support/relationships, attitudes and health services. The EF Item Set contains 9 dichotomous items with an identical response option but without a sum score because of its multidimensional nature .
The between-treatment difference in change from Baseline in global disease assessment (patient)
• The patient's global assessment of disease activity will be performed using a 100 mm VAS ranging from not severe to very severe, after the question "How active was your disease on average during the last week?"
The between-treatment difference in change from Baseline in global disease assessment (physician)
• The physician's global assessment of disease activity will be performed using 100 mm VAS ranging from no disease activity to maximal disease activity, after the question "Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today." To enhance objectivity, the physician must not be aware of the specific patient's global assessment of disease activity when performing his own assessment on that patient.
The between-treatment difference in change from Baseline in pain
• The patient's assessment of back pain will be performed using a 100 mm VAS ranging from no pain to unbearable pain, after the question "Based on your assessment, please indicate what is the amount of back pain at any time that you experienced during the last week?" and "Based on your assessment, please indicate what is the amount of back pain at night that you experienced during the last week?".

Full Information

First Posted
March 26, 2019
Last Updated
July 6, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03906136
Brief Title
AScalate: Treat-to-target in Axial Spondyloarthritis
Acronym
AScalate
Official Title
A Randomized, Open Label Multicenter Trial to Investigate the Efficacy of a Treat-to-target (T2T) Treatment Strategy With Secukinumab (AIN457) as a First-line Biologic Compared to a Standard-of-care (SOC) Treatment Over 36 Weeks in Patients With Active Axial Spondyloarthritis (axSpA)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
September 22, 2022 (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
Yes

5. Study Description

Brief Summary
This is a randomized, parallel-group, open-label, multicenter study of patients with active axSpA. The aim is to demonstrate that the efficacy of a Treat-to-Target (T2T) approach (with secukinumab as first-line biologic) is superior to a Standard-Of-Care (SOC) approach in terms of achieving strong clinical efficacy in patients with active axial Spondyloarthritis (axSpA) who are naïve to biological therapy and who have had an inadequate response to non-steroidal anti-inflammatory drugs. The study will include an 8-week Screening period, a 36-week treatment period according to previous randomization, and a safety follow-up period of 20 weeks. The primary endpoint is the percentage of patients achieving an Assessment in SpondyloArthritis international Society response 40 (ASAS40) at Week 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
axial spondyloarthritis, axSpA, treat-to-target, T2T, secukinumab, AIN457, Non-Radiographic Axial Spondyloarthritis, nr-axSpA, Radiographic Axial Spondyloarthritis, r-axSpA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TREAT-TO-TARGET (T2T)
Arm Type
Experimental
Arm Description
Participants received secukinumab at a dose of 150 milligrams (mg) as subcutaneous (s.c.) injection at 150 mg dose at Baseline, Week 1, 2, 3, 4 and 8. From Week 12, only responders continued to receive 4-weekly doses until Week 32 if they maintained the response. In the event these patients experienced a loss of response from week 24 they were escalated to secukinumab 300 mg s.c. every 4 weeks until Week 32. Patients who were non-responders at Week 12 will received 4-weekly secukinumab 300 mg s.c. until Week 24. From Week 24, only responders continued to receive 4-weekly secukinumab 300 mg s.c. until Week 32. Patients who are non-responders to secukinumab 300 mg at Week 24 receive biweekly of adalimumab biosimilar 40 mg s.c. until Week 34
Arm Title
Standard-of-care (SOC)
Arm Type
Active Comparator
Arm Description
SOC treatment up to the maximum recommended dose at the discretion of the investigator as according to current recommendation for treatment of axSpA
Intervention Type
Biological
Intervention Name(s)
Secukinumab/Adalimumab-Biosimilar
Intervention Description
Secukinumab 150 mg, s.c. Secukinumab 300 mg, s.c. Adalimumab-Biosimilar, s.c.
Intervention Type
Other
Intervention Name(s)
Standard-of-care
Intervention Description
Patients will receive treatment according to local practice standards by their treating physician following the current treatment recommendations.
Primary Outcome Measure Information:
Title
Percentage of patients achieving an Assessment of responders for the SpondyloArthritis International Society (ASAS) 40 response
Description
The ASAS response measures consist of the following Domains: Patient's global assessment of disease activity measured on a visual analog scale (VAS). Patient's assessment of back pain, represented by either total or nocturnal pain scores, both measured on a VAS scale. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by VAS. Inflammation represented by mean duration and severity of morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) as measured by VAS scale. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment C-Reactive Protein (CRP) ASAS40 response is defined as an improvement of ≥ 40% and ≥ 2 units on a scale of 10 in at least 3 of the 4 domains and no worsening at all in the remaining domain.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients achieving an ASAS40 response
Description
ASAS40 response is defined as an improvement of ≥ 40% and ≥ 2 units on a scale of 10 in at least 3 of the 4 domains and no worsening at all in the remaining domain.
Time Frame
Week 12
Title
Percentage of patients achieving ASAS20, ASAS partial response
Description
ASAS20 response is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 0 to 10 in at least 3 of the 4 domains, and no worsening at all in the remaining domain. ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10.
Time Frame
Week 12 and week 24
Title
The proportion of patients meeting the Ankylosing Spondylitis Disease Activity Score (ASDAS) definition of inactive disease, ASDAS clinically important and major improvement and ASDAS low disease activity
Description
Parameters used for the ASDAS include spinal pain (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive Protein or Erythrocyte Sedimentation Rate). The 3 values selected to separate disease activity states were < 1.3 between inactive disease and low disease activity, < 2.1 between low disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement".
Time Frame
Week 12 and week 24
Title
The proportion of patients achieving the Bath Ankylosing Spondylitis Disease Activity Index response 50% (BASDAI 50) at Week 12 and Week 24
Description
The BASDAI consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of the disease
Time Frame
Week 12 and week 24
Title
The between-treatment difference in change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS. The 10 questions were chosen with major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the patients' ability to cope with everyday life. A 0 through 10 scale (captured as a continuous VAS) is used to answer the questions. The mean of the 10 scales gives the BASFI score - a value between 0 and 10.
Time Frame
Week 12 and week 24
Title
The between-treatment difference in change from Baseline in Bath ankylosing spondylitis metrology index (BASMI) and chest expansion
Description
The BASMI is a validated instrument that uses the minimum number of clinically appropriate measurements that accurately assess axial status, with the goal to define clinically significant changes in spinal movement. Parameters include: Lateral spinal flexion Tragus-to-wall distance Lumbar flexion (modified Schoeber) Maximal intermalleolar distance Cervical rotation angle Additionally, the following assessments should be taken: Chest expansion Occiput-to-wall distance
Time Frame
Week 12 and week 24
Title
Change from baseline in the ASQoL (Ankylosing Spondylitis Quality of Life instrument)
Description
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). As such, lower scores indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the questionnaire requires approximately 6 minutes to complete. The purpose of the ASQoL is to assess the disease specific QoL of patients in this study.
Time Frame
Week 12 and week 24
Title
The between-treatment difference in change from baseline in ASAS-HI (Ankylosing Spondyloarthritis International Society Health Index)
Description
The ASAS-HI is a disease-specific questionnaire that was developed based on the comprehensive International Classification of Functioning, Disability and Health Core Set (also known as the ICF Core Set) for AS. The ASAS HI is a linear composite measure and contains 17 items (dichotomous response option: "I agree" and "I do not agree"), which cover most of the ICF Core Set. The ASAS HI contains items addressing categories of pain, emotional functions, sleep, sexual function, mobility, self-care, and community life. The total sum of the ASAS HI ranges from 0 to 17, with a lower score indicating a better health status. In addition, the Environmental Factor (EF) Item Set contains items addressing categories of support/relationships, attitudes and health services. The EF Item Set contains 9 dichotomous items with an identical response option but without a sum score because of its multidimensional nature .
Time Frame
Week 12 and week 24
Title
The between-treatment difference in change from Baseline in global disease assessment (patient)
Description
• The patient's global assessment of disease activity will be performed using a 100 mm VAS ranging from not severe to very severe, after the question "How active was your disease on average during the last week?"
Time Frame
Week 12 and week 24
Title
The between-treatment difference in change from Baseline in global disease assessment (physician)
Description
• The physician's global assessment of disease activity will be performed using 100 mm VAS ranging from no disease activity to maximal disease activity, after the question "Considering all the ways the disease affects your patient, draw a line on the scale for how well his or her condition is today." To enhance objectivity, the physician must not be aware of the specific patient's global assessment of disease activity when performing his own assessment on that patient.
Time Frame
Week 12 and week 24
Title
The between-treatment difference in change from Baseline in pain
Description
• The patient's assessment of back pain will be performed using a 100 mm VAS ranging from no pain to unbearable pain, after the question "Based on your assessment, please indicate what is the amount of back pain at any time that you experienced during the last week?" and "Based on your assessment, please indicate what is the amount of back pain at night that you experienced during the last week?".
Time Frame
Week 12 and week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Axial Spondyloarthritis, axSpA (either Non-Radiographic Axial Spondyloarthritis or Radiographic Axial Spondyloarthritis) fulfilling the Ankylosing Spondyloarthritis International Society classification criteria for axSpA Active disease as defined by having an Ankylosing Spondylitis Disease Activity Score ≥ 2.1 at Screening and Baseline despite concurrent Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy, or intolerance/contraindication to NSAIDs. Objective signs of inflammation at Screening as defined by: Magnetic Resonance Imaging (MRI) of sacroiliac joints performed up to 3 months prior to screening showing acute inflammatory lesion(s), OR elevated quick C-reactive Protein (CRP) (> 5 mg/L), OR MRI showing acute inflammatory lesion(s) in the sacroiliac joints and spine performed during screening period. Inadequate response to NSAIDs Exclusion Criteria: Previous exposure to secukinumab or other biologic drug directly targeting Interleukin(IL)-17 or IL-17 receptor. Patients who have previously been treated with Tumor Necrosis Factor Alpha inhibitors (investigational or approved). Patients treated with any cell-depleting therapies. Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunosuppressed the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy. History of clinically significant liver disease or liver injury History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum creatinine level exceeding 1.8 mg/dL (159.12 μmol/L). Active systemic infections during the last 2 weeks (exception: common cold) prior to randomization. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis (TB) infection Patients positive for human immunodeficiency virus, hepatitis B or hepatitis C Life vaccinations within 6 weeks prior to Baseline or planned vaccination during study participation until 12 weeks after last study treatment administration. Other protocol-defined inclusion/exclusion criteria may apply.
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
Orleans
State/Province
Cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Novartis Investigative Site
City
Nice
State/Province
Cedex1
ZIP/Postal Code
06001
Country
France
Facility Name
Novartis Investigative Site
City
Limoges
State/Province
Haute Vienne
ZIP/Postal Code
87000
Country
France
Facility Name
Novartis Investigative Site
City
Caluire et Cuire
ZIP/Postal Code
69300
Country
France
Facility Name
Novartis Investigative Site
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Novartis Investigative Site
City
Grenoble
ZIP/Postal Code
B P 217X
Country
France
Facility Name
Novartis Investigative Site
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Novartis Investigative Site
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Novartis Investigative Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Novartis Investigative Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Novartis Investigative Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Novartis Investigative Site
City
Bad Doberan
ZIP/Postal Code
18209
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Pyrmont
ZIP/Postal Code
31812
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Novartis Investigative Site
City
Chemnitz
ZIP/Postal Code
09130
Country
Germany
Facility Name
Novartis Investigative Site
City
Cottbus
ZIP/Postal Code
03042
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Ehringshausen
ZIP/Postal Code
35630
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91056
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiberg
ZIP/Postal Code
09599
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Novartis Investigative Site
City
Gommern
ZIP/Postal Code
39245
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Novartis Investigative Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Novartis Investigative Site
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80639
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14469
Country
Germany
Facility Name
Novartis Investigative Site
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Facility Name
Novartis Investigative Site
City
Rendsburg
ZIP/Postal Code
24768
Country
Germany
Facility Name
Novartis Investigative Site
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89073
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
Citations:
PubMed Identifier
32998926
Citation
Poddubnyy D, Hammel L, Heyne M, Veit J, Jentzsch C, Baraliakos X. Treat-to-target strategy with secukinumab as a first-line biological disease modifying anti-rheumatic drug compared to standard-of-care treatment in patients with active axial spondyloarthritis: protocol for a randomised open-label phase III study, AScalate. BMJ Open. 2020 Sep 30;10(9):e039059. doi: 10.1136/bmjopen-2020-039059.
Results Reference
derived

Learn more about this trial

AScalate: Treat-to-target in Axial Spondyloarthritis

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