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 · 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.
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.
Exclusion criteria:
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.
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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Novartis Pharmaceuticals