Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
- Registration Number
- NCT01892436
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 460
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo - AIN457A 75mg Placebo 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 Placebo - AIN457 150mg Placebo 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 Secukinumab 75mg Secukinumab 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 Secukinumab 150mg Secukinumab 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 Placebo - AIN457A 75mg Secukinumab 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 Placebo - AIN457 150mg Secukinumab 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
- Primary Outcome Measures
Name Time Method Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 weeks 116, 128, 140, 156, 180, 208, 232 and 260 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)Proportion of Subjects Who Reached ACR50 weeks 116, 128, 140, 156, 180, 208, 232 and 260 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)Proportion of Subjects Who Reached ACR70 weeks 116, 128, 140, 156, 180, 208, 232 and 260 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)
- Secondary Outcome Measures
Name Time Method Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) weeks 116, 128, 140, 156, 180, 208, 232 and 260 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.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) weeks 116, 128, 140, 156, 180, 208, 232 and 260 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)Change From Baseline in Disease Activity Score-CRP (DAS28) weeks 116, 128, 140, 156, 180, 208, 232 and 260 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 scorePercentage of Subjects Achieving Low Disease Activity weeks 116, 128, 140, 156, 180, 208, 232 and 260 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
Percentage of Subjects Achieving Disease Remission (DAS28<2.6) weeks 116, 128, 140, 156, 180, 208, 232 and 260 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
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧London, United Kingdom