Clinical Trial: 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety

Brief Summary: The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD or biologic anti-TNFα therapy

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Assessment of American College of Rheumatology 20 (ACR20) [ Time Frame: 16 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Disease Activity Score for 28 joints (DAS28-CRP) utilizing hsCRP [ Time Frame: 16 weeks ]
  The DAS28 response is a validated composite assessment. The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment. DAS28 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
• Psoriatic Area and Severity Index 75 (PASI75) [ Time Frame: 16 weeks ]

  The PASI75 is a measure of disease activity based on extent of the disease, severity of erythema, scaling and thickness in different body areas affected by psoriasis with an improvement in the PASI score of at least 75% compared to baseline.

  PASI75 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.

• Short Form Health Survey Physical Component Score (SF-36-PCS) [ Time Frame: 16 weeks ]
  The SF-36-PCS is a 36 item questionnaire which measures Quality of Life across 8 domains (both physical and emotional). Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. SF-36-PCS is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
• American College of Rheumatology 50 (ACR50) [ Time Frame: 16 weeks ]

  The ACR50 resonse is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvement in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire, pain score on a visual analog scale, patient global assessment, physician global assessment and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)].

  ACR50 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.

• Assessment of American College of Rheumatology 20 (ACR20) [ Time Frame: 4 weeks ]
  The ACR20 response is a validated composite assessment. The patient is defined as an ACR20 responder if there is a ≥ 20% improvement in 3 clinical clinical domains relevant to psoriatic arthritis. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
• Overall safety and tolerability as measured by number of adverse events and serious adverse events [ Time Frame: 112 weeks ]
  These assessments will be implemented in terms of physical examination and vital signs outcomes, clinical laboratory results, nature and frequency of the observed adverse events and serious adverse events, frequency and severity of any injection site reactions, ECG outcomes and the detection of immunogenicity. During the first 24 weeks of the study, comparisons between the secukinumab treatment arms and the placebo treatment arm will also take place.

Original Secondary Outcome:

• Disease Activity Score for 28 joints (DAS28-CRP) utilizing hsCRP [ Time Frame: 16 weeks ]
  The DAS28 response is a validated composite assessment. The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment. DAS28 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
• Psoriatic Area and Severity Index 75 (PASI75) [ Time Frame: 16 weeks ]

  The PASI75 is a measure of disease activity based on extent of the disease, severity of erythema, scaling and thickness in different body areas affected by psoriasis with an improvement in the PASI score of at least 75% compared to baseline.

  PASI75 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.

• Short Form Health Survey Physical Component Score (SF-36-PCS) [ Time Frame: 16 weeks ]
  The SF-36-PCS is a 36 item questionnaire which measures Quality of Life across 8 domains (both physical and emotional). Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. SF-36-PCS is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
• American College of Rheumatology 50 (ACR50) [ Time Frame: 16 weeks ]

  The ACR50 resonse is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvement in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire, pain score on a visual analog scale, patient global assessment, physician global assessment and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)].

  ACR50 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.

• Assessment of American College of Rheumatology 20 (ACR20) [ Time Frame: 4 weeks ]
  The ACR20 response is a validated composite assessment. The patient is defined as an ACR20 responder if there is a ≥ 20% improvement in 3 clinical clinical domains relevant to psoriatic arthritis. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.
• Overall safety and tolerability (physical examination, vital signs outcomes, clinical laboratory results, adverse events,serious adverse events, injection site reactions, ECG outcomes and immunogenicity [ Time Frame: 112 weeks ]
  These assessments will be implemented in terms of physical examination and vital signs outcomes, clinical laboratory results, nature and frequency of the observed adverse events and serious adverse events, frequency and severity of any injection site reactions, ECG outcomes and the detection of immunogenicity. During the first 24 weeks of the study, comparisons between the secukinumab treatment arms and the placebo treatment arm will also take place.

Dates:
Date Received: November 17, 2014
Date Started: May 2015
Date Completion: December 2017
Last Updated: June 2, 2016
Last Verified: June 2016