Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004246-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Experimental | AIN457 |
|
| Ustekinumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Biological | Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28 | The disability assessment component of the HAQ evaluated a subject's level of functional ability through 20 questions grouped into 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item began with the prompt "Over the past week, are you able to…" and is scored on a 4-point scale: 0 (no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The overall score was calculated by averaging the scores across all answered domains, resulting in a total score ranging from 0 (no disability) to 3 (severe disability). A HAQ-DI response was defined as an improvement of ≥0.35 points from baseline at Week 28. Missing values were imputed as non-responders | Baseline, Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 28 | The Psoriasis Area and Severity Index (PASI) was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved at least a 90% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Rendsburg | Schleswig-Holstein | 24768 | Germany | ||
| Novartis Investigative Site |
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
Not provided
Not provided
Not provided
Not provided
A total of 144 patients overall were screened and 25 patients failed screening, while 119 patients completed the screening period successfully and underwent randomization
Patients were randomized in 28 study sites across Germany
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab | Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24. |
| FG001 | Ustekinumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2024 | Sep 24, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ustekinumab | Biological | Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio |
|
| Baseline, Week 28 |
| Change From Baseline in Patient's Assessment of Pain on VAS at Week 28 | The patient's level of pain was evaluated using a horizontal Visual Analogue Scale (VAS), on which individuals marked their pain intensity with a vertical tick. The scale ranged from 0 mm (indicating "no pain") to 100 mm (indicating "unbearable pain"). The change in the patient's pain assessment on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement. | Baseline, Week 28 |
| Change From Baseline in Tender Joint Count (TJC) 68 at Week 28 | Tender joint count (TJC) 68 was a method of assessing joint inflammation. Number of tender joints was determined by examining 68 joints and identifying the joints that were painful under pressure or to passive motion. The 68 joints assessed for tenderness included the 2 temporomandibular, 2 sternoclavicular, 2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, 2 hips, 2 knees, 2 talo¬tibial, 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet. The change from baseline in TJC68 at Week 28 was assessed. A negative change from baseline indicated improvement. | Baseline, Week 28 |
| Change From Baseline in Swollen Joint Count (SJC) 66 at Week 28 | Swollen Joint Count (SJC) 66 was a method of assessing joint inflammation. The number of swollen joints was determined by examining 66 joints and identifying those with visible or palpable swelling suggestive of synovitis. The 66 joints assessed for swelling included the 2 sternoclavicular, 2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, 2 knees, 2 talotibial, 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet. The change from baseline in SJC66 at Week 28 was assessed. A negative change from baseline indicated improvement. | Baseline, Week 28 |
| Number of Patients Achieving PASI 100 at Week 28 | The PASI was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved 100% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders. | Bseline, Week 28 |
| Number of Patients Achieving PASI 75 at Week 28 | The Psoriasis Area and Severity Index (PASI) was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved at least a 75% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders. | Baseline, Week 28 |
| Change From Baseline in Patient's Global Assessment of Disease Activity on VAS | The patient's global assessment of disease activity was performed using a 100 mm (VAS) ranging from 0 (='very good') to 100 (='very poor') after the question 'Considering all the ways Psoriatic Arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are today'. The change in the patient's global assessment on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement. | Baseline, Week 28 |
| Change From Baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS | The patient's assessment of psoriasis and arthritis was performed using a 100 mm VAS ranging from 0 (='Excellent') to 100 (='Poor') after the question 'Considering all the ways PSORIASIS and ARTHRITIS affects you, please indicate with a vertical mark through the horizontal line how well you are doing over the past week' The change in the patient's global assessment of psoriasis and arthritis disease activity on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement. | Baseline, Week 28 |
| Number of Patients Achieving Minimal Disease Activity (MDA) at Week 28 | MDA was a composite endpoint used to assess low disease activity in patients with psoriatic arthritis and psoriasis. A patient was considered to have achieved MDA if they met at least 5 of the following 7 criteria:
The number of participants achieving MDA at Week 28 was assessed. Missing values were imputed as non-responders. | Week 28 |
| Change From Baseline in the Leeds Enthesitis Index (LEI) | The LEI was a validated enthesitis index that used six sites to evaluate enthesitis: the left and right lateral epicondyles of the humerus, the left and right proximal Achilles tendon insertions, and the left and right medial femoral condyles.Each site was scored as 0 (non-tender) or 1 (tender), resulting in a total score ranging from 0 to 6. A higher score reflected a greater burden of enthesitis. The change in the LEI score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in enthesitis severity | Baseline, Week 28 |
| Change From Baseline in the Leeds Dactylitis Index (LDI) | The LDI was used to quantitatively assess dactylitis by measuring the circumference of affected digits and their corresponding control digits, along with the tenderness of each affected digit. Digits were classified as dactylitic if there was a ≥10% difference in circumference compared to the contralateral digit. When both digits were affected or a contralateral control was unavailable, a standardized reference range was applied. For each dactylitic digit, the ratio of the affected to control circumference was multiplied by a binary tenderness score (1 = tender, 0 = non-tender). The resulting values were summed across all affected digits to calculate the total LDI score. Scores ranged from 0 to 20, with higher scores indicating more severe or widespread dactylitis. The change in the LDI score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in dactylitis severity. | Baseline, Week 28 |
| Change From Baseline in Psoriatic Arthritis Quality of Life (PsAQoL) | The PsAQoL questionnaire was used to assess the impact of psoriatic arthritis on patients' quality of life. The PsAQoL is a validated, disease-specific, self-administered instrument consisting of 20 items with binary response options ("true" or "not true"). Items covered physical, emotional, and social domains, including fatigue, independence, and interpersonal relationships. The total score ranged from 0 to 20, with higher scores indicating greater impairment in quality of life. The change in the PsAQoL score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in health-related quality of life. | Baseline, Week 28 |
| Percentage of Participants Achieving a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Response at Week 28 | The FACIT-Fatigue Scale was used to assess fatigue and its impact on daily functioning over the previous 7 days. The instrument consisted of 13 self-administered items, each scored on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Very much"). The total score ranged from 0 to 52, with higher scores indicating less fatigue and better functioning. Response was achieved if the score had improved by at least 4 points from baseline. Missing values were imputed as non-responders | Baseline, Week 28 |
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Response at Week 28 | The DLQI was used to evaluate the impact of dermatological conditions on patients' quality of life over the previous 7 days. It consisted of 10 self-administered items covering symptoms, daily activities, leisure, work/school, personal relationships, and treatment burden. Each item was scored from 0 ("Not at all") to 3 ("Very much"), with a total score ranging from 0 to 30. Higher scores indicated greater impairment. Response was achieved if the absolute score was either 0 or 1. Missing values were imputed as non-responders. | Week 28 |
| Aachen |
| 52074 |
| Germany |
| Novartis Investigative Site | Bad Bentheim | 48455 | Germany |
| Novartis Investigative Site | Bad Doberan | 18209 | Germany |
| Novartis Investigative Site | Berlin | 12435 | Germany |
| Novartis Investigative Site | Berlin | 13125 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Bochum | 44791 | Germany |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Cologne | 51149 | Germany |
| Novartis Investigative Site | Cottbus | 03042 | Germany |
| Novartis Investigative Site | Dresden | 01067 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Ehringshausen | 35630 | Germany |
| Novartis Investigative Site | Erlangen | 91056 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Gommern | 39245 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hamburg | 22391 | Germany |
| Novartis Investigative Site | Herne | 44649 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Magdeburg | 39104 | Germany |
| Novartis Investigative Site | Magdeburg | 39110 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | München | 81541 | Germany |
| Novartis Investigative Site | Planegg | 82152 | Germany |
| Novartis Investigative Site | Ratingen | 40878 | Germany |
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants >100 kg). One active injection was administered at Baseline, Week 4, and 16. To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab | Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24. |
| BG001 | Ustekinumab | Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants >100 kg). One active injection was administered at Baseline, Week 4, and 16. To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28 | The disability assessment component of the HAQ evaluated a subject's level of functional ability through 20 questions grouped into 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item began with the prompt "Over the past week, are you able to…" and is scored on a 4-point scale: 0 (no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The overall score was calculated by averaging the scores across all answered domains, resulting in a total score ranging from 0 (no disability) to 3 (severe disability). A HAQ-DI response was defined as an improvement of ≥0.35 points from baseline at Week 28. Missing values were imputed as non-responders | The Full Analysis Set (FAS) comprised all patients to whom study treatment (investigational or control treatment) was assigned by randomization. | Posted | Count of Participants | Participants | Baseline, Week 28 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 28 | The Psoriasis Area and Severity Index (PASI) was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved at least a 90% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. | Posted | Count of Participants | Participants | Baseline, Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient's Assessment of Pain on VAS at Week 28 | The patient's level of pain was evaluated using a horizontal Visual Analogue Scale (VAS), on which individuals marked their pain intensity with a vertical tick. The scale ranged from 0 mm (indicating "no pain") to 100 mm (indicating "unbearable pain"). The change in the patient's pain assessment on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Tender Joint Count (TJC) 68 at Week 28 | Tender joint count (TJC) 68 was a method of assessing joint inflammation. Number of tender joints was determined by examining 68 joints and identifying the joints that were painful under pressure or to passive motion. The 68 joints assessed for tenderness included the 2 temporomandibular, 2 sternoclavicular, 2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, 2 hips, 2 knees, 2 talo¬tibial, 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet. The change from baseline in TJC68 at Week 28 was assessed. A negative change from baseline indicated improvement. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Swollen Joint Count (SJC) 66 at Week 28 | Swollen Joint Count (SJC) 66 was a method of assessing joint inflammation. The number of swollen joints was determined by examining 66 joints and identifying those with visible or palpable swelling suggestive of synovitis. The 66 joints assessed for swelling included the 2 sternoclavicular, 2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, 2 knees, 2 talotibial, 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet. The change from baseline in SJC66 at Week 28 was assessed. A negative change from baseline indicated improvement. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Achieving PASI 100 at Week 28 | The PASI was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved 100% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. | Posted | Count of Participants | Participants | Bseline, Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Achieving PASI 75 at Week 28 | The Psoriasis Area and Severity Index (PASI) was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions-each graded on a scale from 0 (none) to 4 (severe)-across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity. The number of participants who achieved at least a 75% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. | Posted | Count of Participants | Participants | Baseline, Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient's Global Assessment of Disease Activity on VAS | The patient's global assessment of disease activity was performed using a 100 mm (VAS) ranging from 0 (='very good') to 100 (='very poor') after the question 'Considering all the ways Psoriatic Arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are today'. The change in the patient's global assessment on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS | The patient's assessment of psoriasis and arthritis was performed using a 100 mm VAS ranging from 0 (='Excellent') to 100 (='Poor') after the question 'Considering all the ways PSORIASIS and ARTHRITIS affects you, please indicate with a vertical mark through the horizontal line how well you are doing over the past week' The change in the patient's global assessment of psoriasis and arthritis disease activity on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Achieving Minimal Disease Activity (MDA) at Week 28 | MDA was a composite endpoint used to assess low disease activity in patients with psoriatic arthritis and psoriasis. A patient was considered to have achieved MDA if they met at least 5 of the following 7 criteria:
The number of participants achieving MDA at Week 28 was assessed. Missing values were imputed as non-responders. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. | Posted | Count of Participants | Participants | Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Leeds Enthesitis Index (LEI) | The LEI was a validated enthesitis index that used six sites to evaluate enthesitis: the left and right lateral epicondyles of the humerus, the left and right proximal Achilles tendon insertions, and the left and right medial femoral condyles.Each site was scored as 0 (non-tender) or 1 (tender), resulting in a total score ranging from 0 to 6. A higher score reflected a greater burden of enthesitis. The change in the LEI score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in enthesitis severity | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Leeds Dactylitis Index (LDI) | The LDI was used to quantitatively assess dactylitis by measuring the circumference of affected digits and their corresponding control digits, along with the tenderness of each affected digit. Digits were classified as dactylitic if there was a ≥10% difference in circumference compared to the contralateral digit. When both digits were affected or a contralateral control was unavailable, a standardized reference range was applied. For each dactylitic digit, the ratio of the affected to control circumference was multiplied by a binary tenderness score (1 = tender, 0 = non-tender). The resulting values were summed across all affected digits to calculate the total LDI score. Scores ranged from 0 to 20, with higher scores indicating more severe or widespread dactylitis. The change in the LDI score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in dactylitis severity. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Psoriatic Arthritis Quality of Life (PsAQoL) | The PsAQoL questionnaire was used to assess the impact of psoriatic arthritis on patients' quality of life. The PsAQoL is a validated, disease-specific, self-administered instrument consisting of 20 items with binary response options ("true" or "not true"). Items covered physical, emotional, and social domains, including fatigue, independence, and interpersonal relationships. The total score ranged from 0 to 20, with higher scores indicating greater impairment in quality of life. The change in the PsAQoL score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in health-related quality of life. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. Only participants with both a baseline and a Week 28 assessment were included in the analysis | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Response at Week 28 | The FACIT-Fatigue Scale was used to assess fatigue and its impact on daily functioning over the previous 7 days. The instrument consisted of 13 self-administered items, each scored on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Very much"). The total score ranged from 0 to 52, with higher scores indicating less fatigue and better functioning. Response was achieved if the score had improved by at least 4 points from baseline. Missing values were imputed as non-responders | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. | Posted | Count of Participants | Participants | Baseline, Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Response at Week 28 | The DLQI was used to evaluate the impact of dermatological conditions on patients' quality of life over the previous 7 days. It consisted of 10 self-administered items covering symptoms, daily activities, leisure, work/school, personal relationships, and treatment burden. Each item was scored from 0 ("Not at all") to 3 ("Very much"), with a total score ranging from 0 to 30. Higher scores indicated greater impairment. Response was achieved if the absolute score was either 0 or 1. Missing values were imputed as non-responders. | FAS: all patients to whom study treatment (investigational or control treatment) was assigned by randomization. | Posted | Count of Participants | Participants | Week 28 |
|
From start of treatment to end of study, assessed up to approximately 36 weeks
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab- On-Treatment | AEs from start of treatment to 30 days after the last dose of study treatment, assessed up to approximately 28 weeks | 0 | 56 | 3 | 56 | 27 | 56 |
| EG001 | Ustekinumab - On-Treatment | AEs from start of treatment to 30 days after the last dose of study treatment, assessed up to approximately 28 weeks | 0 | 63 | 1 | 63 | 31 | 63 |
| EG002 | Secukinumab - Entire Study | AEs from start of treatment to end of study, assessed up to approximately 36 weeks | 0 | 56 | 4 | 56 | 31 | 56 |
| EG003 | Ustekinumab - Entire Study | AEs from start of treatment to end of study, assessed up to approximately 36 weeks | 0 | 63 | 2 | 63 | 32 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal candidiasis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
| |
| Vertebrobasilar stroke | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 862 778 8300 | novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2025 | Sep 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Black |
|
| Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants >100 kg). One active injection was administered at Baseline, Week 4, and 16. To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point. |
|
|
|
|
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants >100 kg). One active injection was administered at Baseline, Week 4, and 16. To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point. |
|
|
|
|
|
|
|
|