A Phase 3 interventional study of Secukinumab and Placebo in Psoriatic Arthritis, sponsored by Novartis Pharmaceuticals. Completed at 77 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 414 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Biological: Secukinumab
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Biological: Secukinumab
Matching Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Biological: Placebo
Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)
Also known as: Secukinumab 150 mg, Secukinumab 300 mg
Secukinumab placebo provided in 1 mL autoinjector
Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
Time frame: Week 24
Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24
A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
Time frame: Week 24
Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24
DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count \[proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)\], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP \< 2.6 is interpreted as remission.
Time frame: Week 24
Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.
Time frame: Week 24
Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24
SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time frame: Week 24
Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.
Time frame: Week 24
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24
The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.
Time frame: Week 24
Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline
The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.
Time frame: Week 24
Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline
The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.
Time frame: Week 24
Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)
Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).
Time frame: From first dose of study treatment to last study visit, up to 3 years
Patients were randomized to 1 of 3 treatment arms (1:1:1) and planned to be treated for 156 weeks. Placebo non-responders had the option to be re-randomized at Week 16 and placebo responders had the option to be re-randomized at Week 24. Thus, of the 137 original placebo patients 64 were re-randomized to AIN457 150 mg and 65 to AIN457 300 mg.
| Milestone | AIN457 150 mg | AIN457 300 mg | Placebo_AIN457 150 mg | Placebo_AIN457 300 mg | Placebo Not Rerandomized |
|---|---|---|---|---|---|
| Started | 138 | 139 | 64 | 65 | 8 |
| Completed | 91 | 102 | 45 | 49 | 0 |
| Not completed | 47 | 37 | 19 | 16 | 8 |
| Withdrew: Adverse event | 10 | 15 | 4 | 5 | 4 |
| Withdrew: Lack of efficacy | 11 | 11 | 7 | 4 | 2 |
| Withdrew: Lost to follow-up | 5 | 2 | 0 | 1 | 1 |
| Withdrew: Physician decision | 4 | 1 | 0 | 1 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Technical problems | 3 | 1 | 3 | 1 | 0 |
| Withdrew: Subject guardian decision | 11 | 6 | 4 | 4 | 1 |
| Withdrew: Death | 3 | 0 | 1 | 0 | 0 |
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
| Participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 | 58 | 67 | 22 |
A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
| Participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24 | 26 | 48 | 12 |
DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count \[proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)\], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP \< 2.6 is interpreted as remission.
| Unit on a scale | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | -1.24 ± 0.095 | -1.56 ± 0.093 | -0.64 ± 0.127 |
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.
| Participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24 | 34 | 29 | 6 |
SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
| Unit on a scale | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Mental Component Summary (MCS) | 1.68 ± 0.837 | 4.41 ± 0.822 | -0.10 ± 1.142 |
| Physical Component Summary (PCS) | 3.42 ± 0.600 | 6.46 ± 0.590 | 2.94 ± 0.830 |
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.
| Participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24 | 25 | 21 | 4 |
The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.
| Unit on a scale | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24 | -0.27 ± 0.043 | -0.38 ± 0.042 | -0.17 ± 0.055 |
The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.
| Participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline | 22 | 24 | 31 |
The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.
| Participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline | 60 | 53 | 83 |
Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).
| Participants | Any AIN457 150 mg | Any AIN457 300 mg | Any AIN457 | Placebo |
|---|---|---|---|---|
| AEs by Primary System Organ Class (SOC) | 176 | 230 | 363 | 81 |
| SAEs by Primary System Organ Class (SOC) | 42 | 35 | 76 | 9 |
| Deaths by Primary System Organ Class (SOC) | 4 | 0 | 4 | 0 |
Collected over All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Any AIN457 150 mg | 4/202 (2%) | 42/202 (20.8%) | 153/202 (75.7%) |
| Any AIN457 300 mg | 0/284 (0%) | 35/284 (12.3%) | 201/284 (70.8%) |
| Any AIN457 | 4/406 (1%) | 76/406 (18.7%) | 320/406 (78.8%) |
| Placebo | 0/137 (0%) | 9/137 (6.6%) | 65/137 (47.4%) |
| Event | Any AIN457 150 mg | Any AIN457 300 mg | Any AIN457 | Placebo |
|---|---|---|---|---|
| PneumoniaInfections and infestations | 3/202 | 1/284 | 4/406 | 0/137 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/202 | 4/284 | 6/406 | 1/137 |
| Myocardial infarctionCardiac disorders | 2/202 | 0/284 | 2/406 | 0/137 |
| Urinary tract infectionInfections and infestations | 2/202 | 0/284 | 2/406 | 0/137 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/202 | 0/284 | 2/406 | 0/137 |
| Arteriosclerosis coronary arteryCardiac disorders | 0/202 | 0/284 | 0/406 | 1/137 |
| Atrial flutterCardiac disorders | 0/202 | 0/284 | 0/406 | 1/137 |
| Atrioventricular block completeCardiac disorders | 1/202 | 0/284 | 1/406 | 1/137 |
| Colitis ulcerativeGastrointestinal disorders | 0/202 | 1/284 | 1/406 | 1/137 |
| Infectious mononucleosisInfections and infestations | 0/202 | 0/284 | 0/406 | 1/137 |
| Event | Any AIN457 150 mg | Any AIN457 300 mg | Any AIN457 | Placebo |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 44/202 | 63/284 | 105/406 | 16/137 |
| Upper respiratory tract infectionInfections and infestations | 27/202 | 35/284 | 61/406 | 7/137 |
| Back painMusculoskeletal and connective tissue disorders | 17/202 | 24/284 | 41/406 | 1/137 |
| Psoriatic arthropathyMusculoskeletal and connective tissue disorders | 20/202 | 21/284 | 41/406 | 5/137 |
| DiarrhoeaGastrointestinal disorders | 20/202 | 19/284 | 39/406 | 2/137 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 17/202 | 23/284 | 40/406 | 1/137 |
| HeadacheNervous system disorders | 18/202 | 18/284 | 36/406 | 7/137 |
| CoughRespiratory, thoracic and mediastinal disorders | 17/202 | 12/284 | 29/406 | 6/137 |
| BronchitisInfections and infestations | 11/202 | 23/284 | 34/406 | 6/137 |
| FatigueGeneral disorders | 16/202 | 10/284 | 26/406 | 2/137 |
| Age, Categorical(Participants) | AIN457 150 mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 126 | 123 | 118 | 367 |
| >=65 years | 12 | 16 | 19 | 47 |
| Sex: Female, Male(Participants) | AIN457 150 mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 77 | 72 | 78 | 227 |
| Male | 61 | 67 | 59 | 187 |
| Race/Ethnicity, Customized(Participants) | AIN457 150 mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 0 | 2 |
| Asian | 2 | 3 | 4 | 9 |
| White | 129 | 130 | 133 | 392 |
| Other | 5 | 6 | 0 | 11 |
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
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