Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis
CompletedPhase 4Results postedLast updated 8 October 2021
What this trial tests
Phase 4 trial testing Secukinumab (AIN457) 150 mg s.c. in Ankylosing Spondylitis in 211 participants. Completed in 24 September 2019.
18 and older, any sex, with Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Patients Who Achieved ASAS20 Response in the Pooled Secukinumab Group Compared With the Placebo Group at Week 12Primary· Baseline, Week 12
ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response is defined as an improvement from baseline of ≥20% and ≥1 unit on a scale of 0-10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 0-10 in the remaining domain. The four main ASAS domains are: Patient's global assessment of disease activity, back pain, function represented by ability to perform specific tasks (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]) and inflammation represented by mean duration and severity of morning stiffness.
Non-re
Group
Value
95% CI
Secukinumab - Pooled
72
Placebo
31
Proportion of Patients Who Achieved ASAS20 Response in Each Secukinumab Group (Delayed NSAID Tapering and Early NSAID Tapering) Compared With the Placebo GroupSecondary· Baseline, Week 12, Week 16
ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response is defined as an improvement from baseline of ≥20% and ≥1 unit on a scale of 0-10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 0-10 in the remaining domain. The four main ASAS domains are: Patient's global assessment of disease activity, back pain, function represented by ability to perform specific tasks (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]) and inflammation represented by mean duration and severity of morning stiffness.
Non-re
Week 12
Group
Value
95% CI
Secukinumab - Delayed NSAID Tapering
37
Secukinumab - Early NSAID Tapering
35
Placebo
31
Week 16
Group
Value
95% CI
Secukinumab - Delayed NSAID Tapering
40
Secukinumab - Early NSAID Tapering
35
Placebo
29
Mean Change From Baseline in ASAS-NSAID Score at Week 12Secondary· Baseline, Week 12
ASAS-NSAID score is used to present the NSAID (nonsteroidal anti-inflammatory drug) intake by considering the type of NSAID, the total dose and the number of days taking NSAID during a period of interest (PI). For the NSAID equivalence scoring system, "no NSAID intake" was set to a score value of 0, and the reference dose of 150 mg/day diclofenac was set to a score value of 100. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac. ASAS-NSAID score = (equivalent NSAID score) x (days of intake during P
Group
Value
95% CI
Secukinumab - Delayed NSAID Tapering
-44.9
± 47.32
Secukinumab - Early NSAID Tapering
-40.3
± 71.48
Placebo
-31.5
± 36.54
Secukinumab - Pooled
-42.6
± 60.53
Mean Change From Baseline in ASAS-NSAID Score in Each Secukinumab Group After 12 Weeks of Exposure (at Week 12 in the Secukinumab-delayed NSAID Tapering Group and at Week 16 in the Secukinumab-early NSAID Tapering Group)Secondary· Baseline, Week 12 (delayed NSAID tapering), Week 16 (early NSAID tapering)
ASAS-NSAID score is used to present the NSAID (nonsteroidal anti-inflammatory drug) intake by considering the type of NSAID, the total dose and the number of days taking NSAID during a period of interest (PI). For the NSAID equivalence scoring system, "no NSAID intake" was set to a score value of 0, and the reference dose of 150 mg/day diclofenac was set to a score value of 100. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac. ASAS-NSAID score = (equivalent NSAID score) x (days of intake during P
Group
Value
95% CI
Secukinumab - Delayed NSAID Tapering
-44.9
± 47.32
Secukinumab - Early NSAID Tapering
-42.5
± 68.62
Mean Change From Baseline in the BASDAI Total ScoreSecondary· Baseline, Week 12, Week 16
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to ankylosing spondylitis: 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (captured as a continuous visual analog scale). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe symptoms.
A negative chan
Week 12
Group
Value
95% CI
Secukinumab - Delayed NSAID Tapering
-2.1
± 2.16
Secukinumab - Early NSAID Tapering
-2.0
± 2.10
Placebo
-1.8
± 2.00
Secukinumab - Pooled
-2.1
± 2.12
Week 16
Group
Value
95% CI
Secukinumab - Delayed NSAID Tapering
-2.3
± 1.90
Secukinumab - Early NSAID Tapering
-2.0
± 1.96
Placebo
-1.7
± 1.96
Secukinumab - Pooled
-2.2
± 1.93
Mean Change From Baseline in Health-related Quality of Life as Measured by the Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) ScoreSecondary· Baseline, Week 12
The Short Form-36 Health Survey (SF-36) measures the impact of disease on overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36 (SF-36 PCS) that is evaluated in this study. Scores on each item 1-4 were summe
Group
Value
95% CI
Secukinumab - Delayed NSAID Tapering
4.8
± 7.03
Secukinumab - Early NSAID Tapering
6.1
± 6.92
Placebo
4.8
± 7.43
Secukinumab - Pooled
5.5
± 6.98
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post-treatment (median duration of 24 weeks)..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Secukinumab - Delayed NSAID Tapering - Treatment Period 1
Serious: 4/71 (6%)
Deaths: 0/71
Secukinumab - Early NSAID Tapering - Treatment Period 1
Serious: 3/70 (4%)
Deaths: 0/70
Placebo - Treatment Period 1
Serious: 1/70 (1%)
Deaths: 0/70
Secukinumab - Delayed NSAID Tapering - Treatment Period 2
Serious: 1/71 (1%)
Deaths: 0/71
Secukinumab - Early NSAID Tapering - Treatment Period 2
Serious: 0/70 (0%)
Deaths: 0/70
Placebo - Treatment Period 2
Serious: 1/70 (1%)
Deaths: 0/70
Serious adverse events (12 terms)
Reaction
System
Secukinumab - Delayed NSAI…
Secukinumab - Early NSAID …
Placebo - Treatment Period 1
Secukinumab - Delayed NSAI…
Secukinumab - Early NSAID …
Placebo - Treatment Period 2
Iridocyclitis
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Colitis
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Crohn's disease
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Gastritis
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Inguinal hernia
Gastrointestinal disorders
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Oesophageal ulcer
Gastrointestinal disorders
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Erysipelas
Infections and infestations
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Nephrolithiasis
Renal and urinary disorders
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Vaginal cyst
Reproductive system and breast disorders
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Psoriasis
Skin and subcutaneous tissue disorders
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Other adverse events (232 terms — click to expand)
This study assessed the clinical Assessment of SpondyloArthritis international Society (ASAS) 20 response to secukinumab and evaluated to which extent concomitant nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with secukinumab or placebo following an initial run-in phase of stable NSAID therapy.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07390929 — Clinical Trial Study on the Improved New Method of Acupotomy for AS
· NA
· recruiting
NCT06905288 — Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
· recruiting
NCT07166874 — The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 8 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02763046.