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24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01989468
First Posted: November 21, 2013
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
November 7, 2013
November 21, 2013
February 13, 2017
April 10, 2014
January 22, 2018   (Final data collection date for primary outcome measure)
American College of Rheumatology 20 (ACR20) response in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
ACR20 response is used to assess the efficacy of at least one dose of secukinumab versus placebo. An ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvements 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)]
Same as current
Complete list of historical versions of study NCT01989468 on ClinicalTrials.gov Archive Site
  • American College of Rheumatology 50 (ACR50) response in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    ACR50 response is used to assess the efficacy of at least one dose of secukinumab versus placebo. An ACR50 response is defined by at least 50% decreases in the swollen and tender joint count, and at least 50% improvements 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)]
  • Disease Activity Score for 28 joints (DAS28-CRP) (utilizing hsCRP) relative to baseline, assessed in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    DAS28-CRP score is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The DAS28-CRP is a measure of disease activity based on swollen and tender joint counts, high sensitivity CRP and the patient global assessment.
  • Psoriatic Area and Severity Index 75 (PASI75) response in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    PASI75 is used to assess the efficacy of at least one dose of secukinumab versus placebo. PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.
  • Physical function component of the short-form health survey (SF-36-PCS), relative to baseline, in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    The SF-36-PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed.
  • Psoriatic Area and Severity Index 90 (PASI90) response in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    PASI90 is used to assess the efficacy of at least one dose of secukinumab versus placebo. PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.
  • Health Assessment Questionnaire - Disability Index (HAQ-DI score), relative to baseline, in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    HAQ-DI score is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The disability assessment component of the HAQ assesses a subjects level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremitites.
  • Presence of Dactylitis), in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    Dactylitis is used to assess the efficacy of at least one dose of secukinumab versus placebo.
  • Presence of Enthesitis, in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    Enthesitis is used to assess the efficacy of at least one dose of secukinumab versus placebo.
  • Overall safety and tolerability [ Time Frame: 3 years ]
    Safety analyses will include summaries of adverse events, laboratory measurements, ECGs and vital signs
  • Psoriatic Area and Severity Index 75 (PASI75) response in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    PASI75 is used to assess the efficacy of at least one dose of secukinumab versus placebo. PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.
  • Psoriatic Area and Severity Index 90 (PASI90) response in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    PASI90 is used to assess the efficacy of at least one dose of secukinumab versus placebo. PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.
  • Disease Activity Score for 28 joints (DAS28-CRP) (utilizing hsCRP) relative to baseline, assessed in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    DAS28-CRP score is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The DAS28-CRP is a measure of disease activity based on swollen and tender joint counts, high sensitivity CRP and the patient global assessment.
  • Physical function component of the short-form health survey (SF-36-PCS), relative to baseline, in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    The SF-36-PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed.
  • Health Assessment Questionnaire - Disability Index (HAQ-DI score), relative to baseline, in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ]
    HAQ-DI score is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The disability assessment component of the HAQ assesses a subjects level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremitites.
  • American College of Rheumatology 50 (ACR50) response in subjects treated with secukinumab versus placebo [ Time Frame: Week 24 ]
    ACR50 response is used to assess the efficacy of at least one dose of secukinumab versus placebo. An ACR50 response is defined by at least 50% decreases in the swollen and tender joint count, and at least 50% improvements 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)]
  • Treatment emergent adverse events for each treatment group [ Time Frame: 24 weeks ]
    Adverse events will be summarized to include the number and percentage of subjects having an adverse event, the severity of the adverse event, serious adverse events and other significant adverse events that lead to study treatment discontinuation.
Not Provided
Not Provided
 
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis
The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriatic Arthritis
  • Biological: Secukinumab
    Eligible subjects are randomised to each of three treatment arms in a 1:1:1 ratio
  • Biological: Placebo
    Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
  • Experimental: Secukinumab (AIN457) 150 mg s.c.
    Secukinumab 150 mg at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
    Intervention: Biological: Secukinumab
  • Experimental: Secukinumab (AIN457) 300 mg s.c.
    Secukinumab 300 mg at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
    Intervention: Biological: Secukinumab
  • Placebo Comparator: Placebo
    Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
414
January 22, 2018
January 22, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
  • Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
  • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
  • Inadequate control of symptoms with NSAID.

Exclusion Criteria:

  • Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
  • Subjects taking high potency opioid analgesics.
  • Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
  • Ongoing use of prohibited psoriasis treatments / medications.
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
  • Previous treatment with any cell-depleting therapies.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Bulgaria,   Canada,   Czech Republic,   Germany,   Italy,   Netherlands,   Puerto Rico,   Russian Federation,   Spain,   Switzerland,   United Kingdom,   United States
Norway,   Sweden
 
NCT01989468
CAIN457F2318
2013-004002-25 ( EudraCT Number )
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP