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Trial record 1 of 67 for:    Maximise
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Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement (MAXIMISE)

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.
 
ClinicalTrials.gov Identifier: NCT02721966
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Axial Psoratic Arthritis Biological: AIN457 Drug: AIN457 Placebo Phase 3

Detailed Description:
In the anlalysis (CSR), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. So there were 498 participants, and not 503

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Phase 3b

498 patients were randomized. 5 (of 503) patients were mis-randomized, i.e. had number but did never received study medication.

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)
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: AIN457 150mg
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 300mg
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 150 mg 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




Primary Outcome Measures :
  1. 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 :
  1. 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

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

  3. Proportion of patients with response to treatment as assessed by BASDAI50 at week 12 [ Time Frame: at week 12 ]

    Bath ankylosing spondylitis disease activity index (BASDAI) 50 response

    BASDAI 50 response is defined as at least 50% improvement (decrease) in total BASDAI score.


  4. 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.

  5. 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.

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

  7. 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.

  8. 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.

  9. 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.

  10. Proportion of patients with Adverse Events [ Time Frame: at week 52 ]
    physical examinations, vital signs, adverse events, laboratory parameters



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.


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


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02721966    
Other Study ID Numbers: CAIN457F3302
2016-000814-31 ( EudraCT Number )
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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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
axial
Psoriatic Arthritis
PsA
Magnetic resonance imaging
MRI
Additional relevant MeSH terms:
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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