Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Secukinumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01892436

2013-001241-13 (EudraCT Number)

CAIN457F2306E1

Details and patient eligibility

About

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.

Enrollment: 460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 4 patient groups

Secukinumab 75mg

Experimental group

Description:

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

Treatment:

Drug: Secukinumab

Secukinumab 150mg

Experimental group

Description:

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

Treatment:

Drug: Secukinumab

Placebo - AIN457A 75mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Secukinumab

Placebo - AIN457 150mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Secukinumab