An observational study in Axial Spondyloarthritis, Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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.
186 studies on the registry are indexed under Axial Spondyloarthritis; 57 are open to participants now.
This study's planned enrollment of 60 is below the median of 180 across 61 observational studies indexed under Axial Spondyloarthritis.
Browse Axial Spondyloarthritis studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline through Week 20
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: 1. Fatigue 2. Spinal pain 3. Joint pain/swelling 4. Areas of localized tenderness 5. Morning stiffness severity 6. 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.
Time frame: Baseline, Weeks 4, 8, 12, and 16
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Apr 2027, 7 months later.
Of 28 observational studies under Axial Spondyloarthritis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 48. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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