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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02745080




Registration number
NCT02745080
Ethics application status
Date submitted
1/04/2016
Date registered
20/04/2016
Date last updated
21/05/2020

Titles & IDs
Public title
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
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
Secondary ID [1] 0 0
CAIN457F2366
Universal Trial Number (UTN)
Trial acronym
EXCEED 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Secukinumab
Other interventions - Adalimumab

Experimental: Secukinumab 300 mg s.c. - Secukinumab 300 mg will be 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 will be 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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
American College of Rheumatology 20 (ACR20) response - 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)]
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
PASI90 - 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
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
ACR50 response - An ACR50 response is defined by at least 50% decrease 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)]
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Health Assessment Questionnaire - Disability Index (HAQ-DI score), relative to baseline - 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 extremeties.
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Resolution of enthesitis - Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. Resolution is defined as the absence of recorded enthesitis; conducted by the study assessor.
Timepoint [4] 0 0
52 weeks

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [2] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [3] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [4] 0 0
Novartis Investigative Site - Malvern East
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment outside Australia
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United States of America
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California
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Colorado
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Vermont
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Wisconsin
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Pleven
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Czechia
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Czechia
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Uherske Hradiste
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Czechia
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Zlin
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Frederiksberg
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Tartu
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Glasgow
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Hull
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Newcastle Upon Tyne
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Plymouth
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Wigan
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the safety and efficacy of secukinumab monotherapy
and adalimumab monotherapy in patients with active psoriatic arthritis who are naïve to
biologic therapy and are intolerant or having inadequate response to conventional DMARDs
Trial website
https://clinicaltrials.gov/show/NCT02745080
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
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Email 0 0
Contact person for scientific queries

Summary results
Other publications