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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02745080
Registration number
NCT02745080
Ethics application status
Date submitted
1/04/2016
Date registered
20/04/2016
Date last updated
27/01/2021
Titles & IDs
Public title
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
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Scientific title
A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis
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Secondary ID [1]
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2015-004477-32
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Secondary ID [2]
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CAIN457F2366
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Universal Trial Number (UTN)
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Trial acronym
EXCEED 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Musculoskeletal
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0
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Secukinumab
Other interventions - Adalimumab
Experimental: Secukinumab 300 mg s.c. - Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
Active Comparator: Adalimumab 40 mg s.c. - Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
Other interventions: Secukinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Other interventions: Adalimumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52
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Assessment method [1]
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Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The primary endpoint is the proportion of patients with monotherapy ACR20 response at Week 52 where monotherapy ACR20 response is defined as meeting the following 3 conditions:
achieving American College of Rheumatology 20 (ACR20) response
no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit)
no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52
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Assessment method [1]
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The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52
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Assessment method [2]
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Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The secondary endpoint is the proportion of patients with monotherapy ACR50 response at Week 52 where monotherapy ACR50 response is defined as meeting the following 3 conditions:
achieving American College of Rheumatology 50 (ACR50) response
no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 52
no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52
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Assessment method [3]
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The HAQ-DI assesses a subject's 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 extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.
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Timepoint [3]
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Baseline, Week 52
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Secondary outcome [4]
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Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52
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Assessment method [4]
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Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. Resolution was defined as the absence of recorded enthesitis; conducted by the study assessor.
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Timepoint [4]
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Week 52
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Eligibility
Key inclusion criteria
Key
- Diagnosis of PsA classified by CASPAR
- Rheumatoid factor and anti-CCP antibodies negative
- Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >= 2cm
diameter or nail changes consistent with psoriasis or documented history of plaque
psoriasis
- Inadequate control of symptoms with NSAIDs
- Inadequate control of symptoms with a conventional DMARD.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnant or nursing women
- Evidence of ongoing infectious or malignant process
- Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis
- Subjects taking high potency opioid analgesics
- Ongoing use of prohibited psoriasis treatments/medications
- Previous treatment with any cell-depleting therapies including but not limited to
anti-CD20 investigational agents.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/12/2019
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Sample size
Target
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Accrual to date
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Final
853
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Kogarah
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Novartis Investigative Site - Maroochydore
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Novartis Investigative Site - Hobart
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Novartis Investigative Site - Malvern East
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2217 - Kogarah
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4558 - Maroochydore
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7000 - Hobart
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3145 - Malvern East
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This was a randomized, double-blind, active controlled, multicenter, parallel-group study
evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients
with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or
having inadequate response to conventional disease modifying anti-rheumatic drugs (also known
as non-biologic DMARDs).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02745080
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02745080
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