Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

Study Overview
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Brief Summary
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This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

Official Title
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A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: Secukinumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period Subjects must be deemed by the investigator to benefit from continued secukinumab therapy Exclusion criteria Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms Pregnant or nursing (lactating) women Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU) Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab 75mg<br>Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator | Drug: Secukinumab<br>* Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17).<br>* Other names: AIN457;|
| Experimental: Secukinumab 150mg<br>Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator | Drug: Secukinumab<br>* Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17).<br>* Other names: AIN457;|
| Experimental: Placebo - AIN457A 75mg<br>Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg | Drug: Secukinumab<br>* Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17).<br>* Other names: AIN457;Drug: Placebo<br>* Placebo<br>* Other names: Placebo - AIN457A;|
| Experimental: Placebo - AIN457 150mg<br>Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg | Drug: Secukinumab<br>* Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17).<br>* Other names: AIN457;Drug: Placebo<br>* Placebo<br>* Other names: Placebo - AIN457A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 | Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: Patient's assessment of Psoriatic Arthritis (PsA) pain Patient's global assessment of disease activity Physician's global assessment of disease activity Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score) Acute phase reactant (hsCRP or ESR) | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | 
| Proportion of Subjects Who Reached ACR50 | Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: Patient's assessment of PsA pain Patient's global assessment of disease activity Physician's global assessment of disease activity Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score) Acute phase reactant (hsCRP or ESR) | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | 
| Proportion of Subjects Who Reached ACR70 | Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain Patient's global assessment of disease activity Physician's global assessment of disease activity Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score) Acute phase reactant (hsCRP or ESR) | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability) | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | 
| Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) | Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | 
| Change From Baseline in Disease Activity Score-CRP (DAS28) | Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores. DAS28 is a combined measure of disease activity based on the following formula: DAS28-CRP = 0.56*TJC28^0.5 + 0.28*SJC28^0.5 + 0.36*ln(CRP+1) + 0.014*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP < 2.6 Low disease activity is defined as DAS28-CRP < 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | 
| Percentage of Subjects Achieving Low Disease Activity | Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | 
| Percentage of Subjects Achieving Disease Remission (DAS28<2.6) | Percentage of subjects achieving disease remission (DAS28<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission | weeks 116, 128, 140, 156, 180, 208, 232 and 260 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extension study, psoriatic arthritis, pre-filled syringe