A Phase 4 interventional study of 150 mg open-label secukinumab and 150 mg double-blinded secukinumab in Ankylosing Spondylitis, sponsored by Novartis Pharmaceuticals. Completed at 65 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment
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Among 20 studies testing secukinumab in Spondylitis, Ankylosing — 3 open to participants now, 4 under way, none of them phase 3. secukinumab · Spondylitis, Ankylosing.
Among the 20 studies testing secukinumab in Spondylitis, Ankylosing, this one is the 8th largest by enrollment, is the only one that started in 2018, is one of 6 in phase 4, and was the 14th registered.
533 studies on the registry are indexed under Spondylitis, Ankylosing; 99 are open to participants now.
Browse Spondylitis, Ankylosing studies →3 of the 20 studies testing secukinumab in Spondylitis, Ankylosing are open now, in 2 countries. Recruiting first, the newest first:
NYU Langone Health · Sites in United States
Ages 18+
Tongji Hospital · Sites in China
Ages 18–80
The Affiliated Hospital Of Guizhou Medical University · Sites in China
Ages 18+
By country, each count listing its studies:
secukinumab: first FDA approval 2015 (COSENTYX), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 63 Spondylitis, Ankylosing studies recruiting now, 25 (40%) set no upper age limit and 32 (51%) stop at 75 or younger; 10 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 322 is above the median of 88 across 303 interventional studies indexed under Spondylitis, Ankylosing.
Median enrollment 223 across the 20 interventional studies. Of the 15 that completed or were terminated, 15 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 20 have an industry lead sponsor. The 6 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
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.
21 studies in Spondylitis, Ankylosing by Novartis: 2 open now, 2 under way, none of them phase 3. Of 19 finished, 17 (89%) have results posted.
Among the 21 studies in Spondylitis, Ankylosing by Novartis, this one is the 8th largest by enrollment of the 17 interventional ones that give a count, is the only one that started in 2018, is one of 2 in phase 4, and was the 16th registered.
Novartis’s Spondylitis, Ankylosing studies by the year they started, since 2009.
1 of the studies testing secukinumab in Spondylitis, Ankylosing that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06833112The Affiliated Hospital Of Guizhou Medical UniversityInterleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis | 2027-08 |
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Among the 20 studies testing secukinumab in Spondylitis, Ankylosing, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Novartis’s 21 in Spondylitis, Ankylosing:
Nothing recorded among them since 2026-09-25.
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This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis
The study used a multicenter design which included an initial 16 week open-label period (Treatment Period 1) followed by a randomized, double-blind, parallel-group period (Treatment Period 2),
At Week 16, patients were placed into 1 of the following groups:
Note: To minimize patient burden, at the Week 16 Visit, the hs-CRP measurement that is part of the ASDAS calculation was imputed from the Week 12 hs-CRP results to allow for assignment into the groups above. Historically, hs-CRP levels have varied little between Week 12 and Week 16 or in previous studies of secukinumab in active AS.
Patients could discontinue the study at any time. If rescue treatment with prohibited medications (as described in Section 9.4.7) occurred, patients were discontinued from the study and were to return for an End of Study Visit. The End of Study Visit was scheduled approximately 4 weeks after the last study treatment and was performed before any new treatment was initiated. After the End of Study Visit, any serious adverse events (SAEs) that occurred in the following 30 days were required to be reported.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (total score \<1.3) at both Week 12 and Week 16.
Drug: 150 mg open-label secukinumab · Drug: 150 mg double-blinded secukinumab
Patients who have active disease, defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) total score of \>1.3 at both Week 12 and Week 16, and who achieved a decrease (improvement) from baseline in total ASDAS score at both Week 12 and Week 16.
Drug: 150 mg open-label secukinumab · Drug: 150 mg double-blinded secukinumab · Drug: 300 mg double-blinded secukinumab
Patients who exhibit no change or an increase (worsening) from baseline in total Ankylosing Spondylitis Disease Activity Score (ASDAS) score at either Week 12 or Week 16. Non-responders were not entered Treatment Period 2. Non-responders were discontinued from the study at Week 16.
Drug: 150 mg open-label secukinumab
All patients in Treatment Period 1 received 150 mg s.c. injection open-label secukinumab.
Also known as: AIN457
Treatment Period 2 Patients who achieved responder status entered Treatment Period 2 and continued to receive 150 mg s.c. (1 s.c. injection of secukinumab 150 mg)
Also known as: AIN457
Treatment Period 2 300 mg (2 s.c. injections of the 150 mg dose)
Also known as: AIN457
The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure
Proportion of participants with inadequate response at week 16 who achieved inactive disease at Week 52 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) were utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
Time frame: Week 52
The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale
A reduction from baseline in ASDAS score of ≥1.1 was considered a clinically important improvement in disease activity in Ankylosing Spondylitis. In this study, ASDAS is used to estimate the difference in response between 150mg and 300mg of secukinumab. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) wias utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
Time frame: Baseline, Week 52
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Time frame: Baseline, Week 52
Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50)
BASDAI-50 represents a change from baseline (improvement) of at least 50% in BASDAI score. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Time frame: Baseline, Week 52
The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS20 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS20 response is defined as an improvement of ≥20% from baseline and absolute improvement from baseline of at least 1 on a 0-to-10 scale in at least 3 of the following 4 domains: patient global, total back pain, function (BASFI), and inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness). An absence of deterioration from baseline (deterioration defines as ≥20% worsening and absolute worsening of at last 1 on a 0-to-10 scale) in the potential remaining domain.
Time frame: Week 52
The Proportion of Participants Who Achieved an ASAS 40 Response
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS40 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS40 response is defined as a ≥40% improvement in 3 of the 4 domains with an absolute improvement of at least 2 on a 0-to-10 scale, and no worsening in the remaining domain.
Time frame: Week 52
The Proportion of Patients Who Achieved an ASAS Partial Remission
The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 0-10. In this study, ASAS partial remission is used to estimate the difference in response between 150mg and 300mg of secukinumab.
Time frame: Week 52
Change in ASAS - Health Index Over Time
The ASAS-HI is a self-administered questionnaire and measures functioning and health over 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. Patients score each item as "I agree" and "I do not agree". In this study, ASAS-HI is used to estimate the difference in response between 150mg and 300mg of secukinumab. Lower score indicating a better health status
Time frame: Baseline, Week 52
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Over Time
Fatigue was assessed using the 13-item FACIT-fatigue scale for the assessment of fatigue in cancer patients.24 The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.
Time frame: Baseline, Week 52
322 participants were enrolled at 65 sites in the United States
| Milestone | Period 1: Secukinumab 150 mg | Period 2: Secukinumab 300 mg (Period 1 Inadequate Responders) | Secukinumab 150 mg (Period 1 Inadequate Responders) | Secukinumab 150 mg (Period 1 Responders) |
|---|---|---|---|---|
| Started | 322 | 0 | 0 | 0 |
| Non-responders | 50 | 0 | 0 | 0 |
| Inadequate responders | 207 | 0 | 0 | 0 |
| Responders | 22 | 0 | 0 | 0 |
| Completed | 279 | 0 | 0 | 0 |
| Not completed | 43 | 0 | 0 | 0 |
| Withdrew: Adverse event | 10 | 0 | 0 | 0 |
| Withdrew: Technical problems | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 8 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 15 | 0 | 0 | 0 |
| Withdrew: Non-compliance with study treatment | 2 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 3 | 0 | 0 | 0 |
| Milestone | Period 1: Secukinumab 150 mg | Period 2: Secukinumab 300 mg (Period 1 Inadequate Responders) | Secukinumab 150 mg (Period 1 Inadequate Responders) | Secukinumab 150 mg (Period 1 Responders) |
|---|---|---|---|---|
| Started | 0 | 102 | 105 | 22 |
| Completed | 0 | 86 | 88 | 22 |
| Not completed | 0 | 16 | 17 | 0 |
| Withdrew: Adverse event | 0 | 3 | 5 | 0 |
| Withdrew: Technical problem | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 3 | 3 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 3 | 4 | 0 |
| Withdrew: Lack of efficacy | 0 | 6 | 2 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 |
| Withdrew: New therapy for study indication | 0 | 0 | 1 | 0 |
Proportion of participants with inadequate response at week 16 who achieved inactive disease at Week 52 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) were utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
| Participants | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg (IR) |
|---|---|---|
| The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure | 9 | 7 |
A reduction from baseline in ASDAS score of ≥1.1 was considered a clinically important improvement in disease activity in Ankylosing Spondylitis. In this study, ASDAS is used to estimate the difference in response between 150mg and 300mg of secukinumab. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) wias utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.
| Participants | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg (IR) |
|---|---|---|
| The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale | 6 | 3 |
BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab.
| Score on a scale | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg |
|---|---|---|
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 0.18 ± 0.191 | -0.05 ± 0.188 |
BASDAI-50 represents a change from baseline (improvement) of at least 50% in BASDAI score. In this study, BASDAI is used to estimate the difference in response between 150mg and 300mg of secukinumab.
| Participants | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg |
|---|---|---|
| Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50) | 11 | 9 |
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS20 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS20 response is defined as an improvement of ≥20% from baseline and absolute improvement from baseline of at least 1 on a 0-to-10 scale in at least 3 of the following 4 domains: patient global, total back pain, function (BASFI), and inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness). An absence of deterioration from baseline (deterioration defines as ≥20% worsening and absolute worsening of at last 1 on a 0-to-10 scale) in the potential remaining domain.
| Participants | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg |
|---|---|---|
| The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria) | 19 | 22 |
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS40 is used to estimate the difference in response between 150mg and 300mg of secukinumab. An ASAS40 response is defined as a ≥40% improvement in 3 of the 4 domains with an absolute improvement of at least 2 on a 0-to-10 scale, and no worsening in the remaining domain.
| Participants | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg |
|---|---|---|
| The Proportion of Participants Who Achieved an ASAS 40 Response | 10 | 8 |
The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 0-10. In this study, ASAS partial remission is used to estimate the difference in response between 150mg and 300mg of secukinumab.
| Participants | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg |
|---|---|---|
| The Proportion of Patients Who Achieved an ASAS Partial Remission | 12 | 12 |
The ASAS-HI is a self-administered questionnaire and measures functioning and health over 17 aspects of health and 9 environmental factors in patients with spondyloarthritis. Patients score each item as "I agree" and "I do not agree". In this study, ASAS-HI is used to estimate the difference in response between 150mg and 300mg of secukinumab. Lower score indicating a better health status
| scores on a scale | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg |
|---|---|---|
| Change in ASAS - Health Index Over Time | 0.51 ± 0.320 | 0.38 ± 0.315 |
Fatigue was assessed using the 13-item FACIT-fatigue scale for the assessment of fatigue in cancer patients.24 The FACIT-Fatigue is a validated questionnaire that was originally developed for the precise evaluation of fatigue levels in cancer patients with anemia. It consists of 13 questions using a 5 point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added with equal weight to obtain a total score. The range of possible scores is 0-52, with 0 corresponding to the highest level of fatigue and 52 corresponding to the lowest level of fatigue.
| Score | Secukinumab 150 mg - 300 mg (IR) | Secukinumab 150 mg - 150 mg |
|---|---|---|
| Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Over Time | -1.93 ± 0.954 | -0.92 ± 0.938 |
Collected over AEs were collected from first dose of study treatment until end of study treatment at week 52. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Period 2 Secukinumab 150 mg - 150 mg (R) | 0/22 (0%) | 0/22 (0%) | 7/22 (31.8%) |
| Treatment Period 1 Secukinumab 150 mg | 0/322 (0%) | 11/322 (3.4%) | 50/322 (15.5%) |
| Treatment Period 2 Secukinumab 150 mg - 300 mg (IR) | 0/101 (0%) | 7/101 (6.9%) | 30/101 (29.7%) |
| Treatment Period 2 Secukinumab 150 mg - 150 mg (IR) | 0/105 (0%) | 3/105 (2.9%) | 32/105 (30.5%) |
| Event | Treatment Period 2 Secukinumab 150 mg - 150 mg (R) | Treatment Period 1 Secukinumab 150 mg | Treatment Period 2 Secukinumab 150 mg - 300 mg (IR) | Treatment Period 2 Secukinumab 150 mg - 150 mg (IR) |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/22 | 0/322 | 1/101 | 0/105 |
| Coronary artery diseaseCardiac disorders | 0/22 | 0/322 | 1/101 | 0/105 |
| Abdominal painGastrointestinal disorders | 0/22 | 1/322 | 1/101 | 0/105 |
| VomitingGastrointestinal disorders | 0/22 | 0/322 | 1/101 | 0/105 |
| Chest painGeneral disorders | 0/22 | 0/322 | 1/101 | 0/105 |
| Urinary tract infectionInfections and infestations | 0/22 | 0/322 | 1/101 | 0/105 |
| Compression fractureInjury, poisoning and procedural complications | 0/22 | 0/322 | 1/101 | 0/105 |
| Lumbar vertebral fractureInjury, poisoning and procedural complications | 0/22 | 1/322 | 1/101 | 0/105 |
| Pulmonary contusionInjury, poisoning and procedural complications | 0/22 | 0/322 | 1/101 | 0/105 |
| Rib fractureInjury, poisoning and procedural complications | 0/22 | 0/322 | 1/101 | 0/105 |
| Event | Treatment Period 2 Secukinumab 150 mg - 150 mg (R) | Treatment Period 1 Secukinumab 150 mg | Treatment Period 2 Secukinumab 150 mg - 300 mg (IR) | Treatment Period 2 Secukinumab 150 mg - 150 mg (IR) |
|---|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/22 | 15/322 | 6/101 | 10/105 |
| SARS-CoV-2 test negativeInvestigations | 2/22 | 2/322 | 7/101 | 8/105 |
| Ankylosing spondylitisMusculoskeletal and connective tissue disorders | 2/22 | 1/322 | 5/101 | 1/105 |
| Back painMusculoskeletal and connective tissue disorders | 2/22 | 6/322 | 4/101 | 4/105 |
| Upper respiratory tract infectionInfections and infestations | 0/22 | 15/322 | 6/101 | 8/105 |
| DiarrhoeaGastrointestinal disorders | 0/22 | 18/322 | 7/101 | 3/105 |
This is for participants in period 1. 300 mg Arm was not part of Enrollment Set.
| Age, Categorical(Participants) | Secukinumab 150 mg - 150 mg |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 283 |
| >=65 years | 39 |
| Age, Continuous(Mean) | Secukinumab 150 mg - 150 mg |
|---|---|
| Mean | 48.02 ± 13.692 |
| Sex: Female, Male(Participants) | Secukinumab 150 mg - 150 mg |
|---|---|
| Female | 155 |
| Male | 167 |
| Race/Ethnicity, Customized(Participants) | Secukinumab 150 mg - 150 mg |
|---|---|
| Caucasian | 284 |
| Black | 18 |
| Asian | 11 |
| Native American | 1 |
| Pacific Islander | 0 |
| Other | 3 |
| Unknown | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
Ran from Mar 2018 to primary completion in Mar 2021, 35 months.
Results were first posted in Apr 2022, 1 year after primary completion.
Of 18 phase 4 interventional studies under Spondylitis, Ankylosing, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 36. This study's 35 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Secukinumab