Axial SpondyloarthritisNCT07737730
A Study to Assess the Safety of Subcutaneous Secukinumab for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
An observational study of Axial Spondyloarthritis and Ankylosing Spondylitis, run by Novartis Pharmaceuticals.
Trial summary
The aim of this study is to assess the safety of secukinumab in Indian adult participants with axSpA, AS, and nr-axSpA over a 16-week treatment period. The present study is being undertaken to fulfill the Post Marketing Surveillance (PMS) mandate by the Health Authority (HA) to evaluate the safety of secukinumab… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with axSpA, AS, and nr-axSpA for whom the treating physician prescribes treatment with secukinumab 150 mg subcutaneous as part of routine clinical care.
Who may be able to join
- Participant or his/her legally acceptable representative (LAR) who are willing to voluntarily provide signed informed consent for participation in the study.
- Adult male or female participants (≥18 years) diagnosed with axSpA, AS, and nr-axSpA.
Who cannot join
- Participants who meet any contraindication outlined in the current Prescribing Information (PI)/Package Insert for secukinumab at the time of screening.
- Pregnant or lactating women.
- Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: A Prospective, Observational, Multicentre Study to Assess the Safety of Subcutaneous Secukinumab 150 mg Solution for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA) Over a Period of 16 Weeks
The aim of this study is to assess the safety of secukinumab in Indian adult participants with axSpA, AS, and nr-axSpA over a 16-week treatment period. The present study is being undertaken to fulfill the Post Marketing Surveillance (PMS) mandate by the Health Authority (HA) to evaluate the safety of secukinumab solution for injection administered subcutaneously in a pre-filled pen in the indicated population under real-world clinical practice conditions.
- Keywords
- Axial Spondyloarthritis,, Ankylosing Spondylitis,, Non-Radiographic Axial Spondyloarthritis, Secukinumab, Quality of Life
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab Cohort | Adult participants diagnosed with axSpA, AS, and nr-axSpA for whom the treating physician prescribes treatment with secukinumab 150 mg subcutaneous as per approved label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: Baseline through Week 20
Secondary outcomes (1)
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a validated diagnostic tool used to assess disease activity and effectiveness of treatment in AS participants. It consists of 6 questions pertaining to the 5 major symptoms of AS:
- Fatigue
- Spinal pain
- Joint pain/swelling
- Areas of localized tenderness
- Morning stiffness severity
- Morning stiffness duration
Participants answer each question using a Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem. The scores from questions 1-4 are summed and added to the mean score of questions 4 and 5. The resulting 0-50 score is divided by 5 to obtain the overall BASDAI score. Higher BASDAI scores indicate higher disease activity.
Measured: Baseline, Weeks 4, 8, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737730
- Sponsor's protocol ID
- CAIN457FIN02
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multicentre Study to Assess the Safety of Subcutaneous Secukinumab 150 mg Solution for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA) Over a Period of 16 Weeks
- ClinicalTrials.gov ID
- NCT07737730
- Acronym / sponsor ID
- CAIN457FIN02
- Keywords
- Axial Spondyloarthritis,, Ankylosing Spondylitis,, Non-Radiographic Axial Spondyloarthritis, Secukinumab, Quality of Life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the safety of secukinumab in Indian adult participants with axSpA, AS, and nr-axSpA over a 16-week treatment period. The present study is being undertaken to fulfill the Post Marketing Surveillance (PMS) mandate by the Health Authority (HA) to evaluate the safety of secukinumab solution for injection administered subcutaneously in a pre-filled pen in the indicated population under real-world clinical practice conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab Cohort | – | –Adult participants diagnosed with axSpA, AS, and nr-axSpA for whom the treating physician prescribes treatment with secukinumab 150 mg subcutaneous as per approved label. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with axSpA, AS, and nr-axSpA for whom the treating physician prescribes treatment with secukinumab 150 mg subcutaneous as part of routine clinical care.
Key inclusion criteria (2 listed)
- Participant or his/her legally acceptable representative (LAR) who are willing to voluntarily provide signed informed consent for participation in the study.
- Adult male or female participants (≥18 years) diagnosed with axSpA, AS, and nr-axSpA.
Key exclusion criteria (3 listed)
- Participants who meet any contraindication outlined in the current Prescribing Information (PI)/Package Insert for secukinumab at the time of screening.
- Pregnant or lactating women.
- Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline through Week 20
1 secondary outcome
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline, Weeks 4, 8, 12, and 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Axial Spondyloarthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis and Ankylosing Spondylitis, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline through Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.