Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Secukinumab — DRUG
  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).
• Placebo — DRUG
  Placebo

Study Details

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.

Key Dates

Start date

Sep 30, 2013

Status verified

May 2019

Primary completion

Jan 11, 2018

Completion

Jan 11, 2018

Study Design

Enrollment

460 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Secukinumab 75mg
  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
• Experimental: Secukinumab 150mg
  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
• Experimental: Placebo - AIN457A 75mg
  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
• Experimental: Placebo - AIN457 150mg
  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 Measure

Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20 [ Time Frame: weeks 116, 128, 140, 156, 180, 208, 232 and 260 ]

Locations (22)

Find similar trials in Anniston, AL

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