Psoriatic arthritis MedDRA version: 19.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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. Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 402 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
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 exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term efficacy of secukinumab (provided as pre-filled syringes) with respect to ACR20, ACR50 and ACR70 response over time up to Week 260 in subjects with active psoriatic arthritis and who complete the phase III study CAIN457F2306; Secondary Objective: 1. To evaluate the long-term efficacy of secukinumab with respect to: - Changes in HAQ-DI relative to baseline over time up to Week 260 - The proportion of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID) over time up to Week 260 - The changes in DAS28 (utilizing hsCRP) relative to baseline over time up to Week 260 - The proportion of subjects achieving low disease activity (DAS28 =3.2) and disease remission as defined by DAS28 (DAS28 <2.6) over time up to Week 260 2. To evaluate the long term safety and tolerability of secukinumab as assessed by vital signs, clinical laboratory variables, and adverse events monitoring over time up to Week 260 ;Primary end point(s): ACR20, ACR50 and ACR70;Timepoint(s) of evaluation of this end point: Over the entire duration of the study up to Week 260 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) - Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI) - Change from baseline in DAS28 - Subjects achieving low disease activity and disease remission - Safety and tolerability ;Timepoint(s) of evaluation of this end point: Over the entire duration of the study up to Week 260 | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Germany, Israel, Italy, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Thailand, United Kingdom, United States
Contacts
Public ContactMedical Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed