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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01989468
First received: November 7, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Psoriatic Arthritis
Biological: Secukinumab
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • American College of Rheumatology 20 (ACR20) response in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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)]


Secondary Outcome Measures:
  • Psoriatic Area and Severity Index 75 (PASI75) response in subjects treated with secukinumab versus placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    PASI 90 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 405
Study Start Date: April 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab (AIN457) 150 mg s.c.
secukinumab 150 mg (1.0 ml) plus placebo (1.0 ml) at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
Biological: Secukinumab
Eligible subjects are randomised to each of three treatment arms in a 1:1:1 ratio
Experimental: Secukinumab (AIN457) 300 mg s.c.
secukinumab 300 mg (2 x 1.0 ml) at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Biological: Secukinumab
Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio
Placebo Comparator: Placebo
Placebo (2 x 1.0 ml) at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Biological: Placebo
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989468

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 104 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01989468     History of Changes
Other Study ID Numbers: CAIN457F2318, 2013-004002-25
Study First Received: November 7, 2013
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Psoriatic arthritis
AIN457
PsA
ACR
CASPAR
PASDAS
secukinumab
autoinjector

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014