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Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement (MAXIMISE)

This study is currently recruiting participants.
Verified November 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02721966
First Posted: March 29, 2016
Last Update Posted: November 17, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

Condition Intervention Phase
Axial Psoratic Arthritis Biological: AIN457 Drug: AIN457 Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab), a Randomized, Double-blind, Placebo-controlled, Multicenter, 52 Week Study to Assess the Efficacy and Safety of Secukinumab 150 mg or 300 mg s.c. in Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non Steroidal Anti-inflammatory Drugs (NSAIDs)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Assessment of spondyloarthritis international society (ASAS) 20 response [ Time Frame: at week 12 ]
    Proportion of patients with response to treatment (300 mg AIN457) as assessed by the ASAS 20 criteria at week 12


Secondary Outcome Measures:
  • Assessment of spondyloarthritis international society (ASAS) 20 response [ Time Frame: at week 12 ]
    Proportion of patiens with response to treatment (150 mg AIN457) as assessed by the ASAS 20 criteria at week 12

  • Assessment of spondyloarthritis international society (ASAS) 40 response [ Time Frame: at week 12 ]
    Proportion of patiens with response to treatment as assessed by the Assessment of spondyloarthritis international society (ASAS) 40 criteria at week 12.

  • Bath ankylosing spondylitis disease activity index (BASDAI) 50 response [ Time Frame: at week 12 ]
    BASDAI 50 response is defined as at least 50% improvement (decrease) in total BASDAI score.

  • Spinal pain visual analog scale (VAS) scale [ Time Frame: at baseline, at week 12 ]
    Change from baseline in spinal pain VAS scale at week 12.

  • Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index [ Time Frame: at baseline, at week 12 ]
    Change from baseline in SPARCC enthesitis index at week 12.

  • Health Health assessment questionnaire - disability index (HAQ-DI) [ Time Frame: at baseline, at week 12 ]
    Change from baseline in HAQ-DI at week 12.

  • Functional assessment of chronic illness therapy fatigue scale (FACIT-Fatigue) [ Time Frame: at baseline, at week 12 ]
    Change from baseline in FACIT-Fatigue at week 12.

  • Assessment of spondyloarthritis international society (ASAS) Health Index [ Time Frame: at baseline, at week 12 ]
    Change from baseline in ASAS Health Index at week 12.

  • American College of Rheumatology (ACR) 20 response [ Time Frame: at week 12 ]
    Proportion of patients with response to treatment as assessed by the ACR 20 criteria at week 12.

  • Percentage of patients with Adverese Events [ Time Frame: at week 12 ]
    physical examinations, vital signs, adverse events, laboratory parameters


Estimated Enrollment: 495
Actual Study Start Date: October 3, 2016
Estimated Study Completion Date: May 20, 2019
Estimated Primary Completion Date: August 17, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 dose 1
Secukinumab dose amount 1 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 1 sc injection every 4 weeks for remaining 44 weeks
Biological: AIN457
Anti IL-17a monoclonal antibody
Other Name: Secukinumab
Experimental: AIN457 dose 2
Secukinumab dose amount 2 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 2 sc injection every 4 weeks for remaining 44 weeks
Biological: AIN457
Anti IL-17a monoclonal antibody
Other Name: Secukinumab
Placebo Comparator: AIN457 Placebo
Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab dose 1 or 300 mg sc injection every 4 week for remaining 40 weeks.
Biological: AIN457
Anti IL-17a monoclonal antibody
Other Name: Secukinumab
Drug: AIN457 Placebo
Placebo matching AIN457

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed
  • Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
  • Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
  • Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
  • Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period

Exclusion Criteria:

  • History of exposure to other IL-17 or IL-23 inhibitor biologic drug
  • History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
  • Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
  • Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
  • Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician

Other protocol-defined inclusion and exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721966


Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 105 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02721966     History of Changes
Other Study ID Numbers: CAIN457F3302
2016-000814-31 ( EudraCT Number )
First Submitted: March 23, 2016
First Posted: March 29, 2016
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Assessment of spondyloarthritis international society (ASAS)
ASAS
axial
Psoriatic Arthritis (PsA)
PsA
Magnetic resonance imaging (MRI)
MRI

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
Anti-Inflammatory Agents, Non-Steroidal
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents