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

September 9, 2020 updated by: Novartis Pharmaceuticals

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

503

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, BE-B-1200
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1070
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1413
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1505
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1784
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 63800
        • Novartis Investigative Site
      • Bruntal, Czechia, 792 01
        • Novartis Investigative Site
      • Plzen-Bory, Czechia, 30599
        • Novartis Investigative Site
      • Uherske Hradiste, Czechia, 686 01
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 10138
        • Novartis Investigative Site
      • Tartu, Estonia, 50406
        • Novartis Investigative Site
  • Finland
      • Kuopio, Finland, 70100
        • Novartis Investigative Site
      • Kuovola, Finland, 45100
        • Novartis Investigative Site
  • France
      • Lyon, France, 69003
        • Novartis Investigative Site
      • Nantes, France, 44000
        • Novartis Investigative Site
      • PARIS Cedex 13, France, 75651
        • Novartis Investigative Site
      • Toulouse Cedex, France, 31059
        • Novartis Investigative Site
      • Vandoeuvre Les Nancy, France, 54511
        • Novartis Investigative Site
    • Cedex
      • Strasbourg, Cedex, France, 67098
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10789
        • Novartis Investigative Site
      • Bochum, Germany, 44791
        • Novartis Investigative Site
      • Cottbus, Germany, 03042
        • Novartis Investigative Site
      • Hamburg, Germany, 22391
        • Novartis Investigative Site
      • Magdeburg, Germany, 39110
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 27
        • Novartis Investigative Site
      • Athens, Greece, 12462
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1023
        • Novartis Investigative Site
      • Eger, Hungary, 3300
        • Novartis Investigative Site
      • Heviz, Hungary, 8380
        • Novartis Investigative Site
      • Miskolc, Hungary, H-3529
        • Novartis Investigative Site
      • Veszprem, Hungary, 8200
        • Novartis Investigative Site
  • Ireland
      • Dublin 8, Ireland
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 343621
        • Novartis Investigative Site
      • Kfar Saba, Israel, 44281
        • Novartis Investigative Site
      • Ramat Gan, Israel, 52621
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Novartis Investigative Site
  • Italy
      • Bologna, Italy, 40138
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24128
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Novartis Investigative Site
      • Torino, TO, Italy, 10128
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italy, 37134
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15 351
        • Novartis Investigative Site
      • Bydgoszcz, Poland, 85 168
        • Novartis Investigative Site
      • Krakow, Poland, 31-121
        • Novartis Investigative Site
      • Piotrkow Trybunalski, Poland, 97-300
        • Novartis Investigative Site
      • Poznan, Poland, 60-773
        • Novartis Investigative Site
      • Poznan, Poland, 60 529
        • Novartis Investigative Site
      • Warszawa, Poland, 02637
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 030167
        • Novartis Investigative Site
      • Bucuresti, Romania, 011172
        • Novartis Investigative Site
      • Cluj Napoca, Romania, 400006
        • Novartis Investigative Site
  • Russian Federation
      • Izhevsk, Russian Federation, 426009
        • Novartis Investigative Site
      • Kazan, Russian Federation, 420064
        • Novartis Investigative Site
      • Khanty-Mansiysk, Russian Federation, 628012
        • Novartis Investigative Site
      • Kursk, Russian Federation, 305007
        • Novartis Investigative Site
      • Moscow, Russian Federation, 123182
        • Novartis Investigative Site
      • Moscow, Russian Federation, 119049
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115093
        • Novartis Investigative Site
      • Novosibirsk, Russian Federation, 630099
        • Novartis Investigative Site
      • Orenburg, Russian Federation, 460000
        • Novartis Investigative Site
      • Saratov, Russian Federation, 410053
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150062
        • Novartis Investigative Site
  • Spain
      • A Coruna, Spain, 15006
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
      • Pontevedra, Spain, 36001
        • Novartis Investigative Site
      • Sevilla, Spain, 41010
        • Novartis Investigative Site
      • Vitoria Gasteiz, Spain, 01009
        • Novartis Investigative Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Novartis Investigative Site
    • Andalucia
      • Cordoba, Andalucia, Spain, 14004
        • Novartis Investigative Site
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Novartis Investigative Site
    • Castilla Y Leon
      • Salamanca, Castilla Y Leon, Spain, 37007
        • Novartis Investigative Site
    • Cataluna
      • Barcelona, Cataluna, Spain, 08003
        • Novartis Investigative Site
    • Galicia
      • Lugo, Galicia, Spain, 27003
        • Novartis Investigative Site
      • Santiago de Compostela, Galicia, Spain, 15706
        • Novartis Investigative Site
    • Las Palmas De G.C
      • Las Palmas de Gran Canaria, Las Palmas De G.C, Spain, 35020
        • Novartis Investigative Site
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigative Site
      • St Gallen, Switzerland, CH 9007
        • Novartis Investigative Site
      • Zuerich, Switzerland, CH 8091
        • Novartis Investigative Site
    • CH
      • Fribourg, CH, Switzerland, 1708
        • Novartis Investigative Site
  • United Kingdom
      • Hull, United Kingdom, HU3 2JZ
        • Novartis Investigative Site
      • Wigan, United Kingdom, WN6 9EP
        • Novartis Investigative Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Novartis Investigative Site
    • Barnstaple
      • Devon, Barnstaple, United Kingdom, EX31 4JB
        • Novartis Investigative Site
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Novartis Investigative Site
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Novartis Investigative Site
    • London
      • Leytonstone, London, United Kingdom, E11 1NR
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD5 0NA
        • Novartis Investigative Site
      • Leeds, West Yorkshire, United Kingdom, LS7 4SA
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 have applied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: Secukinumab
Anti IL-17a monoclonal antibody
Other Names:
  • AIN457
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: Secukinumab
Anti IL-17a monoclonal antibody
Other Names:
  • AIN457
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: Secukinumab
Anti IL-17a monoclonal antibody
Other Names:
  • AIN457
Drug: Secukinumab and Placebo
Placebo matching AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12
Time Frame: at week 12

Purpose of this measure: was to demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg was established

ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥10 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Response to Treatment (150 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12
Time Frame: at week 12

Purpose of this key secondary measure: was to demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg was established. 300mg and 150mg are presented side by side for clarity; and to align with protocol. 300mg data is for Primary outcome; and 150mg data is for key secondary outcome

ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥10 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
at week 12
Percentage of Participants With Response to Treatment (150 mg/300 mg AIN457) as Assessed by the ASAS40 Criteria at Week 12
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.

ASAS40 was defined as an improvement of ≥40% and absolute improvement of ≥20 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
at week 12
Percentage of Participants 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.
at week 12
Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Any Time
Time Frame: at baseline, at week 12

Change from baseline in Spinal pain visual analog scale (VAS) at week 12

VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best).

VAS measures pain and stress for on a horizontal line of 100 mm, ranging from very low (0) to very high (100).
at baseline, at week 12
Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Night
Time Frame: at baseline, at week 12

Change from baseline in Spinal pain visual analog scale (VAS) at week 12

VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best).

VAS measures pain and stress for on a horizontal line of 100 mm, ranging from very low (0) to very high (100)
at baseline, at week 12
Change From Baseline Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Score at Week 12
Time Frame: baseline and week 12
The Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index score range is 0-16, where 0 is the best outcome, and 16 the worst. The assessor determines whether the site shows tenderness and therefore would count as site with enthesitis. This is done by applying pressure to the site and getting feedback from patient about whether the site is tender.
baseline and week 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
Time Frame: baseline and week 12
The health assessment questionnaire disability index (HAQ-DI) assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.
baseline and week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 12
Time Frame: baseline and week 12
The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52.
baseline and week 12
Change From Baseline in Spondyloarthritis International Society (ASAS) Health Index at Week 12
Time Frame: baseline and week 12

Statistical analysis (using ANCOVA) of change from baseline in spondyloarthritis international society (ASAS) Health Index score by visit - treatment period 1

ASAS HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index.

LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors
baseline and week 12
Percentage of Participants With Response to Treatment as Assessed by the ACR20 Criteria at Week 12
Time Frame: at week 12
American College of Rheumatology 20% (ACR20) Response at Week 12 is the % of responders with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)
at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2016

Primary Completion (Actual)

June 26, 2019

Study Completion (Actual)

June 26, 2019

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457F3302
  • 2016-000814-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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