Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Secukinumab — BIOLOGICAL
  Anti IL-17a monoclonal antibody

Study Details

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

Key Dates

Start date

Aug 31, 2015

Status verified

Apr 2020

Primary completion

Aug 16, 2017

Completion

Jan 24, 2019

Study Design

Enrollment

997 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Secukinumab 150 mg load (Group 1)
  Secukinumab 150 mg sc injection every week for 4 weeks followed by Secukinumab 150 mg every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks until week 100
• Experimental: Secukinumab 150 mg no load (Group 2)
  Secukinumab 150 mg sc injection every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.
• Experimental: Secukinumab 300 mg load (Group 3)
  Secukinumab 300 mg sc injection every week for 4 weeks followed by Secukinumab 300 mg every 4 weeks until week 100
• Placebo Comparator: Placebo arm 1 (Group 4)
  Placebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders will be switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.
• Placebo Comparator: Placebo arm 2 (Group 4)
  Placebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders were switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.

Primary Outcome Measure

Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 [ Time Frame: Week 16 ]

Locations (22)

Find similar trials in Upland, CA

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