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To demonstrate that the efficacy of secukinumab 300 mg at Week 16 was superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.
Treatment Period 1 was defined as the period from Randomization through Week 16 (prior to the Week 16 dose). At the start of placebo-controlled Treatment Period 1, patients were randomized via Interactive Response Technology (IRT) in a 2:2:1 ratio to 1 of 3 treatment groups.
Group 1- Secukinumab 300 mg: secukinumab 300 mg (2 s.c. injections of the 150-mg dose) once weekly for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks.
Group 2- Secukinumab 150 mg: secukinumab 150 mg (1 s.c. injection of the 150-mg dose and 1 s.c. injection of placebo) once weekly for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks.
Group 3- Placebo: placebo (2 s.c. injections of 150 mg secukinumab placebo per dose) once per week for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks.
At each study treatment visit 2 s.c. injections in the form of prefilled syringes (PFS) were administered. This was necessary to maintain the blind, as secukinumab in PFS is available in either 1.0 mL (150 mg) or 2 x 1.0 mL (300 mg). Placebo to secukinumab was also available in 1.0 mL to match the active drug.
Rescue medication was not allowed before completion of Week 16 assessments.
Treatment Period 2 patients receiving secukinumab 300 mg (Group 1) continued to receive the same dose up to Week 48.
At Weeks 16, 28, and 40 patients on secukinumab 150 mg (Group 2) were classified as responders (≥20% improvement from BL in both tender and swollen joint counts) or nonresponders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | secukinumab 300mg s.c. injection |
|
| Group 2 | Active Comparator | secukinumab 150 mg s.c. injection |
|
| Group 3 | Placebo Comparator | Placebo s.c. injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab 300 mg | Drug | 150 mg x 2 s.c. injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 | A patient was considered as improved according to the ACR20 criteria if she/he had at least 20% improvement in two of the following measures:Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR). Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16 | The percent of patients in the Dactylitis Subset with dactylitis in the secukinumab 300 mg group at Week 16. Dactylitis is severe inflammation of the finger and toe joints. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35205 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35428722 | Derived | Nguyen T, Churchill M, Levin R, Valenzuela G, Merola JF, Ogdie A, Orbai AM, Scher JU, Kavanaugh A, Kianifard F, Rollins C, Calheiros R, Chambenoit O. Secukinumab in United States Biologic-Naive Patients With Psoriatic Arthritis: Results From the Randomized, Placebo-Controlled CHOICE Study. J Rheumatol. 2022 Aug;49(8):894-902. doi: 10.3899/jrheum.210912. Epub 2022 Apr 15. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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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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This was a 2-Period study in which participants were randomized to one of three treatment groups (i.e., "secukinumab 300mg s.c. injection", "secukinumab 1500mg s.c. injection" and "placebo s.c. injection") in Period 1 and then some participants switched to Arms/Groups "Group 4", "Group 5", and "Group 6", in Period 2.
Of 349 patients screened for the study, 271 passed screening and 258 were randomized (103 to secukinumab 300 mg, 103 to secukinumab 150 mg, and 52 to placebo). A higher percentage of patients in the secukinumab 300 mg group completed Period 1 (94.2%) than in the secukinumab 150 mg (90.3%) or placebo (88.5%) groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | secukinumab 300mg s.c. injection |
| FG001 | Group 2 | secukinumab 150 mg s.c. injection |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Period 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2016 | Nov 19, 2019 |
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Study design displays results combined as two or more Arms/Groups. Patients assigned to Placebo arm in Treatment Period 1 (TP1) may have switched to Secukinumab 300mg in Treatment Period 2 (TP2). Summaries by group were performed cumulatively by actual treatment received (as follows) for every visit until Week 16 groups in Treatment Period 1: · Secukinumab 300mg (Group 1) · Secukinumab 150mg (Group 2) · Placebo (Group 3) For entire treatment period, summaries by treatment group were performed cumulatively by the actual treatment received (as follows) for every visit til Week 52, including patients who switched at Weeks 16, 28, 40. For safety variables · Any Secukinumab 150 mg (Group 2) · Any Secukinumab 300mg (Group 1) · Any Secukinumab (Group 3) Hence, participants who received "Placebo" in TP1 were combined with participants who received "Any Secukinumab" in "Group 3" and "Any Secukinumab 300mg" in "Group 1" in TP2. Safety is presented for the ENTIRE period, including TP1 and TP2
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| Secukinumab 150 mg | Drug | 150 mg s.c. injection |
|
|
| Placebo | Other | Placebo |
|
|
| Week 16 |
| Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16 | Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | 16 Weeks |
| Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI) | Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. LEI=Leeds Enthesitis Index | 16 Weeks |
| Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI) | Statistical analysis (logistic regression) of presence of enthesitis (Combined SPARCC and LEI) by visit - in treatment period 1 (non-responder imputation) (Combined SPARCC and LEI Subset) Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | 16 Weeks |
| Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | A patient was considered as improved according the ACR50 criteria if she/he had at least 50% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR50 response by visit - in treatment period 1 (non-responder imputation) (Full Analysis Set) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | 16 Weeks |
| Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | A patient was considered as improved according the ACR70 criteria if she/he had at least 70% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR70 response by visit - in treatment period 1 (non-responder imputation) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | 16 Weeks |
| Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. | 16 Weeks |
| Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | A 90% reduction in the Psoriasis Area and Severity Index score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. | 16 Weeks |
| Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | A 100% reduction in the Psoriasis Area and Severity Index score (PASI 100) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | 16 Weeks |
| Change From Baseline to Week 16 in DAS28-CRP | DAS-CRP uses the C-Reactive Protein (CRP) value. Disease Activity Score (DAS28-CRP) values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS28-CRP below the value of 2.6 is interpreted as Remission. DAS28-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters. Least squares mean (LSM), Least squares mean (LSM) treatment difference, 95% confidence interval (CI) for treatment difference, and p-values are from an analysis of covariance (ANCOVA) model with treatment (3 treatment groups), baseline DAS28-CRP score, methotrexate usage at baseline (yes, no), and body weight(kg) as explanatory variables. | baseline, 16 weeks |
| Change From Baseline to Week 16 in HAQ-DI | The Health assessment questionnaire disability index (HAQ-DI) is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled). | 16 Weeks |
| up to 52 weeks |
| Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | up to 52 weeks |
| Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | up to 52 weeks |
| Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | up to 52 weeks |
| Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | up to 52 weeks |
| Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | up to 52 weeks |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Novartis Investigative Site | El Cajon | California | 92020 | United States |
| Novartis Investigative Site | Fountain Valley | California | 92708 | United States |
| Novartis Investigative Site | La Jolla | California | 92093 | United States |
| Novartis Investigative Site | La Mesa | California | 91942 | United States |
| Novartis Investigative Site | Upland | California | 91786 | United States |
| Novartis Investigative Site | Aventura | Florida | 33180 | United States |
| Novartis Investigative Site | Clearwater | Florida | 33765 | United States |
| Novartis Investigative Site | DeBary | Florida | 32713 | United States |
| Novartis Investigative Site | Jacksonville | Florida | 32207 | United States |
| Novartis Investigative Site | North Naples | Florida | 34102 | United States |
| Novartis Investigative Site | Palm Harbor | Florida | 34684 | United States |
| Novartis Investigative Site | Pensacola | Florida | 32514 | United States |
| Novartis Investigative Site | Plantation | Florida | 33324 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34239 | United States |
| Novartis Investigative Site | Tampa | Florida | 33609 | United States |
| Novartis Investigative Site | Tampa | Florida | 33613 | United States |
| Novartis Investigative Site | Duluth | Georgia | 30096 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21224 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | United States |
| Novartis Investigative Site | Worcester | Massachusetts | 01655 | United States |
| Novartis Investigative Site | Battle Creek | Michigan | 49015 | United States |
| Novartis Investigative Site | Kalamazoo | Michigan | 49008 | United States |
| Novartis Investigative Site | Eagan | Minnesota | 55121 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68516 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89106 | United States |
| Novartis Investigative Site | Ridgewood | New Jersey | 07450 | United States |
| Novartis Investigative Site | Summit | New Jersey | 07901 | United States |
| Novartis Investigative Site | Albany | New York | 12206 | United States |
| Novartis Investigative Site | Brooklyn | New York | 11201 | United States |
| Novartis Investigative Site | Lake Success | New York | 11402 | United States |
| Novartis Investigative Site | Orchard Park | New York | 14127 | United States |
| Novartis Investigative Site | Potsdam | New York | 13676 | United States |
| Novartis Investigative Site | Saranac Lake | New York | 12983 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28226 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27408 | United States |
| Novartis Investigative Site | New Bern | North Carolina | 28562 | United States |
| Novartis Investigative Site | Marion | Ohio | 43302 | United States |
| Novartis Investigative Site | Perrysburg | Ohio | 43551 | United States |
| Novartis Investigative Site | Duncansville | Pennsylvania | 16635 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29460 | United States |
| Novartis Investigative Site | Greenville | South Carolina | 29601 | United States |
| Novartis Investigative Site | Orangeburg | South Carolina | 29118-2475 | United States |
| Novartis Investigative Site | Jackson | Tennessee | 38305 | United States |
| Novartis Investigative Site | Arlington | Texas | 76014 | United States |
| Novartis Investigative Site | Arlington | Texas | 77373 | United States |
| Novartis Investigative Site | Austin | Texas | 78731 | United States |
| Novartis Investigative Site | Dallas | Texas | 75231 | United States |
| Novartis Investigative Site | Dallas | Texas | 75246 | United States |
| Novartis Investigative Site | Houston | Texas | 77074 | United States |
| Novartis Investigative Site | Mesquite | Texas | 75150 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84132 | United States |
| Novartis Investigative Site | Seattle | Washington | 98122 | United States |
| Novartis Investigative Site | Spokane | Washington | 99204 | United States |
| Novartis Investigative Site | Santurce | 00909 | Puerto Rico |
| FG002 |
| Group 3 |
Placebo s.c. injection |
| FG003 | Group 4 | Secukinumab 150 mg - 150 mg (R) |
| FG004 | Group 5 | Secukinumab 150 mg - 300 mg (NR) |
| FG005 | Group 6 | Placebo - Secukinumab 300 mg |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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Randomized Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | secukinumab 300mg s.c. injection |
| BG001 | Group 2 | secukinumab 150 mg s.c. injection |
| BG002 | Group 3 | Placebo s.c. injection |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 | A patient was considered as improved according to the ACR20 criteria if she/he had at least 20% improvement in two of the following measures:Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR). Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16 | The percent of patients in the Dactylitis Subset with dactylitis in the secukinumab 300 mg group at Week 16. Dactylitis is severe inflammation of the finger and toe joints. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | Dactylitis Subset: The Dactylitis Subset comprises patients who have LDI >= 1 at baseline | Posted | Number | percent of participants | Week 16 |
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| Secondary | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16 | Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC) subset. The SPARCC Subset is comprised of patients who have SPARCC >= 1 at baseline. Score range is 0-16 sites where a higher indicates more enthesitis. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI) | Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. LEI=Leeds Enthesitis Index | LEI subset: The LEI Subset comprises patients who have LEI >= 1 at baseline. LEI uses 6 sites for evaluation of enthesitis, so the range is 0-6 withy a higher number indicating more arthritis. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI) | Statistical analysis (logistic regression) of presence of enthesitis (Combined SPARCC and LEI) by visit - in treatment period 1 (non-responder imputation) (Combined SPARCC and LEI Subset) Enthesitis, also called enthesopathy, is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | Combined SPARCC and LEI Subset: The LEI and SPARCC Subset comprises patients who have an enthesitis score >= 1 when sites from LEI and SPARCC are assessed together at baseline. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | A patient was considered as improved according the ACR50 criteria if she/he had at least 50% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR50 response by visit - in treatment period 1 (non-responder imputation) (Full Analysis Set) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Patients Achieving ACR70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16 | A patient was considered as improved according the ACR70 criteria if she/he had at least 70% improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR) Statistical analysis (logistic regression) of ACR70 response by visit - in treatment period 1 (non-responder imputation) Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Patients Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. | Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) >= 3% at baseline | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Patients Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | A 90% reduction in the Psoriasis Area and Severity Index score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. | Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) >= 3% at baseline | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Patients Achieving a PASI100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Week 16 | A 100% reduction in the Psoriasis Area and Severity Index score (PASI 100) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis. Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables. | Psoriasis Subset: The psoriasis subset comprises patients having Body Surface Area (BSA) >= 3% at baseline | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Change From Baseline to Week 16 in DAS28-CRP | DAS-CRP uses the C-Reactive Protein (CRP) value. Disease Activity Score (DAS28-CRP) values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS28-CRP below the value of 2.6 is interpreted as Remission. DAS28-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters. Least squares mean (LSM), Least squares mean (LSM) treatment difference, 95% confidence interval (CI) for treatment difference, and p-values are from an analysis of covariance (ANCOVA) model with treatment (3 treatment groups), baseline DAS28-CRP score, methotrexate usage at baseline (yes, no), and body weight(kg) as explanatory variables. | The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization. | Posted | Least Squares Mean | Standard Deviation | scores on a scale | baseline, 16 weeks |
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| Secondary | Change From Baseline to Week 16 in HAQ-DI | The Health assessment questionnaire disability index (HAQ-DI) is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled). | The Full Analysis Set (FAS) includes all patients assigned study medication. Patients inappropriately randomized (e.g., IRT was called in error for randomization of a screen failed patient) were excluded from analysis set. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization. | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | 16 Weeks |
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| Other Pre-specified | Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP) | Full Analysis Set | Posted | Number | percentage of participants | up to 52 weeks |
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| Other Pre-specified | Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | Full Analysis Set | Posted | Number | percentage of participants | up to 52 weeks |
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| Other Pre-specified | Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | Dactylitis Subset The Dactylitis Subset comprised patients who had LDI ≥1 at baseline. | Posted | Number | percentage of participants | up to 52 weeks |
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| Other Pre-specified | Number and Percentage of Patients With Presence of Enthesitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | Leeds Enthesitis Index (LEI) Subset: The LEI Subset comprised patients who had LEI ≥1 at baseline. | Posted | Number | percentage of participants | up to 52 weeks |
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| Other Pre-specified | Number and Percentage of Patients With Minimal Disease Activity Response by Visit in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | Full Analysis Set | Posted | Number | percentage of participants | up to 52 weeks |
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| Other Pre-specified | Number and Percentage of Patients With PASI75, PASI90 and PASI100 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation) | Exploratory | Psoriasis subset The psoriasis subset comprises patients having Body Surface Area (BSA) >= 3% at baseline | Posted | Number | percentage of participants | up to 52 weeks |
|
Adverse events (AE) were collected from first dose of study treatment until end of study treatment up to maximum duration of 52 weeks plus 12 weeks follow up
An AE is any untoward sign or symptom that occurs in >=5% of participants during study treatment.
AEs were counted based on the last actual dose received prior to onset of the AE. The secukinumab 300mg group included patients who received secukinumab 300mg for the entire study and those who switched to secukinumab 300mg in Treatment Period 2
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 300mg | Secukinumab 300mg | 0 | 191 | 15 | 191 | 66 | 191 |
| EG001 | Secukinumab 150mg | Secukinumab 150mg | 0 | 103 | 4 | 103 | 35 | 103 |
| EG002 | Placebo | Placebo | 1 | 52 | 3 | 52 | 12 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Intestinal sepsis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pubic pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Cerebral cyst | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Device loosening | Product Issues | MedDRA (21.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
Period 2 (week 16 up to 52 weeks) contained only exploratory outcomes. AEs are presented cumulitively
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 (ie, 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 | Dec 31, 2018 | Nov 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D001168 | Arthritis |
| D013166 | Spondylitis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Pregnancy |
|
| Technical problems |
|
| Withdrawal of Informed Consent |
|
| ≥40-<65 |
|
| ≥65-<75 |
|
| ≥75 |
|
| Male |
|
| Black |
|
| Caucasian |
|
| Native American |
|
| Other |
|
| Pacific Islander |
|
| Unknown |
|
secukinumab 150 mg s.c. injection, 16 weeks
| Regression, Logistic |
Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation) |
| 0.0961 |
| Odds Ratio (OR) |
| 1.92 |
| 2-Sided |
| 95 |
| 0.89 |
| 4.15 |
| Superiority |
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| Participants |
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|---|---|
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| OG002 | Group 3 | Placebo s.c. injection |
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| OG002 | Group 3 | Placebo s.c. injection |
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| OG002 | Group 3 | Placebo s.c. injection |
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| OG004 | Group 5 | Placebo s.c. injection 300mg |
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