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A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

Primary Purpose

Non-radiographic Axial Spondyloarthritis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Secukinumab
Placebo
Secukinumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-radiographic Axial Spondyloarthritis focused on measuring nr-AxSpa, non-radiographic axial Spondyloarthritis, Secukinumab, remission, withdrawal, inflammatory back pain, sacroiliitis, AIN457

Eligibility Criteria

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

Inclusion Criteria: Male or non-pregnant, non-lactating female participants at least 18 years of age Clinical diagnosis of axSpA AND according to ASAS axSpA criteria: Inflammatory back pain for at least 6 months Onset before 45 years of age Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features Objective signs of inflammation at screening, evident by either MRI with Sacroiliac Joint inflammation (as assessed by central reader) AND / OR hsCRP > ULN (as defined by the central lab) Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline. Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline. Total back pain as measured by VAS (visual analog scale) ≥ 40 mm (0-100 mm) at baseline. Participants should have been on at least 2 different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications. Exclusion Criteria: Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader. Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine). Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFα (tumor necrosis factor α) (unless participants discontinued the treatment with TNFα inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only after appropriate wash-out period prior to baseline was observed). History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes. Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis. Active inflammatory bowel disease. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.

Sites / Locations

  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Period 1

Treatment Period 2

Arm Description

Open-label Secukinumab PFS (prefilled syringe) labeled as AIN457 150mg/1mL

Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo

Outcomes

Primary Outcome Measures

The proportion of participants remaining flare-free during Treatment Period 2
The primary efficacy endpoint is the proportion of participants in the randomized withdrawal population remaining flare-free at Week 120. A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP > 3.5 at any visit during Treatment Period 2, starting at Week 60. Parameters used for ASDAS-CRP include: Spinal pain (BASDAI question 2), Patient's global assessment of disease activity, Peripheral pain/swelling (BASDAI question 3), Duration of morning stiffness (BASDAI question 6) C-reactive protein (CRP) in mg/L

Secondary Outcome Measures

Time to flare during Treatment Period 2
A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP > 3.5 at any visit during Treatment Period 2, starting at Week 60.
Number of participants with Adverse Events
Safety and tolerability demonstrated by assessing: - Adverse events (AEs) and serious adverse events (SAEs)

Full Information

First Posted
November 9, 2022
Last Updated
October 6, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05622708
Brief Title
A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
Official Title
A Multicenter Study of Secukinumab, With a Randomized Double-blind, Placebo-controlled Withdrawal-retreatment Period, to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
April 24, 2030 (Anticipated)
Study Completion Date
June 19, 2030 (Anticipated)

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
This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.
Detailed Description
This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with nr-axSpA who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response Inactive Disease (ID) response (ASDAS-CRP < 1.3). The maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120. Study treatment will be as follows: Open-label Secukinumab PFS (prefilled syringe) will be labeled as AIN457 150mg/1mL Double-blind Secukinumab and Placebo PFS will be labeled as AIN457 150mg/1mL/Placebo. Study duration will be up to 128 weeks from Baseline. The treatment duration will be up to 120 weeks with last treatment administration at Week 116. In the Treatment Period 1 participant will attend a site visit approximately 1 month after Baseline and approximately every 12 weeks thereafter. In the Treatment Period 2 participant will attend site visits approximately every 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-radiographic Axial Spondyloarthritis
Keywords
nr-AxSpa, non-radiographic axial Spondyloarthritis, Secukinumab, remission, withdrawal, inflammatory back pain, sacroiliitis, AIN457

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This phase IV, multicenter study uses a double-blind, placebo-controlled, randomized withdrawal design (Treatment Period 2) preceded by an open label lead-in period (Treatment Period 1).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Period 1
Arm Type
Experimental
Arm Description
Open-label Secukinumab PFS (prefilled syringe) labeled as AIN457 150mg/1mL
Arm Title
Treatment Period 2
Arm Type
Experimental
Arm Description
Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Intervention Description
Treatment Period 1: Open-label secukinumab 150 mg PFS s.c. at baseline, Weeks 1, 2, 3 and 4 followed by administration every four weeks up to Week 52.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment Period 2: Double-blind placebo PFS s.c. every 4 weeks from Week 56 to Week 116.
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Intervention Description
Treatment Period 2: Double-blind secukinumab 150 mg PFS s.c. every 4 weeks from Week 56 to Week 116. Escape re-treatment (during Treatment Period 2): Open-label secukinumab 150 mg PFS s.c.
Primary Outcome Measure Information:
Title
The proportion of participants remaining flare-free during Treatment Period 2
Description
The primary efficacy endpoint is the proportion of participants in the randomized withdrawal population remaining flare-free at Week 120. A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP > 3.5 at any visit during Treatment Period 2, starting at Week 60. Parameters used for ASDAS-CRP include: Spinal pain (BASDAI question 2), Patient's global assessment of disease activity, Peripheral pain/swelling (BASDAI question 3), Duration of morning stiffness (BASDAI question 6) C-reactive protein (CRP) in mg/L
Time Frame
Week 120
Secondary Outcome Measure Information:
Title
Time to flare during Treatment Period 2
Description
A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP > 3.5 at any visit during Treatment Period 2, starting at Week 60.
Time Frame
From Week 56 to Week 120
Title
Number of participants with Adverse Events
Description
Safety and tolerability demonstrated by assessing: - Adverse events (AEs) and serious adverse events (SAEs)
Time Frame
From Baseline to Week 128

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant, non-lactating female participants at least 18 years of age Clinical diagnosis of axSpA AND according to ASAS axSpA criteria: Inflammatory back pain for at least 6 months Onset before 45 years of age Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features Objective signs of inflammation at screening, evident by either MRI with Sacroiliac Joint inflammation (as assessed by central reader) AND / OR hsCRP > ULN (as defined by the central lab) Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline. Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline. Total back pain as measured by VAS (visual analog scale) ≥ 40 mm (0-100 mm) at baseline. Participants should have been on at least 2 different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications. Exclusion Criteria: Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader. Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine). Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFα (tumor necrosis factor α) (unless participants discontinued the treatment with TNFα inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only after appropriate wash-out period prior to baseline was observed). History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes. Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis. Active inflammatory bowel disease. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
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
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36010 570
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90480-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784 400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
ZIP/Postal Code
01409-902
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 11
ZIP/Postal Code
14900
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Orleans
State/Province
Cedex 2
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nice
State/Province
Cedex1
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chambray les Tours
ZIP/Postal Code
37170
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Doberan
ZIP/Postal Code
18209
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rendsburg
ZIP/Postal Code
24768
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Szekesfehervar
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Miskolc
ZIP/Postal Code
H-3529
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ancona
State/Province
AN
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Negrar
State/Province
VR
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Selangor Darul Ehsan
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bydgoszcz
ZIP/Postal Code
85 168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
30 002
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
011055
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cluj Napoca
ZIP/Postal Code
400006
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Suceava
ZIP/Postal Code
727525
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
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

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

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