Overview

This trial is active, not recruiting.

Condition psoriatic arthritis
Treatment secukinumab
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date September 2013
End date November 2017
Trial size 460 participants
Trial identifier NCT01892436, 2013-001241-13, CAIN457F2306E1

Summary

This study is designed as a 3-year extension to the phase III core study CAIN457F2306. It aims 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 will complete the assessments associated with the core study visit and will subsequently continue in the extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity will ensure that subjects who are experiencing worsening of disease in any of the treatment groups can exit the study upon their own wish or based on the advice of the investigator at any time.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Subjects will initially continue 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 be escalated to 150 mg or 300 mg as judged appropriate by investigator
secukinumab AIN457
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).
(Experimental)
Subjects will initially continue 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 be escalated to 300 mg as judged appropriate by the investigator
secukinumab AIN457
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).

Primary Outcomes

Measure
ACR 20, 50 , 70
time frame: Over the entire duration of the study up to Week 260

Secondary Outcomes

Measure
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
time frame: Over the entire duration of the study up to Week 260
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
time frame: Over the entire duration of the study up to Week 260
Change from baseline in DAS28
time frame: Over the entire duration of the study up to Week 260
Subjects achieving low disease activity and disease remission
time frame: Over the entire duration of the study up to Week 260
Safety and tolerability
time frame: Over the entire duration of the study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Novartis.