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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/NCT02294227




Registration number
NCT02294227
Ethics application status
Date submitted
17/11/2014
Date registered
19/11/2014
Date last updated
2/07/2019

Titles & IDs
Public title
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
Scientific title
A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)
Secondary ID [1] 0 0
2014-003849-10
Secondary ID [2] 0 0
CAIN457F2336
Universal Trial Number (UTN)
Trial acronym
FUTURE 4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 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 - Placebo

Experimental: Secukinumab 150 mg - Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator

Experimental: Secukinumab 150 mg No load - Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator

Placebo Comparator: Placebo - Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator


Other interventions: Secukinumab
Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.

Other interventions: Placebo
Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With American College of Rheumatology 20 (ACR20) Response
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16
Timepoint [1] 0 0
week 16
Secondary outcome [2] 0 0
Psoriatic Area and Severity Index 75 (PASI75)
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Short Form Health Survey Physical Component Score (SF-36-PCS)
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Number of Participants With American College of Rheumatology 50 (ACR50)
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Number of Participants With American College of Rheumatology 20 (ACR20) Response
Timepoint [5] 0 0
4 weeks

Eligibility
Key inclusion criteria
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for
Psoriatic ARthritis (CASPAR) criteria.

- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

- Inadequate control of symptoms with NSAID.

- Other protocol-defined inclusion criteria do apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
infectious or malignant process.

- Subjects taking high potency opioid analgesics.

- Previous exposure to secukinumab or other biologic drug directly targeting
interleukin-17 (IL-17) or IL-17 receptor.

- Ongoing use of prohibited psoriasis treatments / medications.

- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFa.

- Previous treatment with any cell-depleting therapies.

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
29/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2017
Sample size
Target
Accrual to date
Final
341
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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Florida
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United States of America
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Illinois
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United States of America
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Louisiana
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United States of America
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Michigan
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Missouri
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United States of America
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Nebraska
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New York
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Oklahoma
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Pennsylvania
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South Carolina
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Washington
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Belgium
State/province [17] 0 0
Aalst
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Belgium
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Bruxelles
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Belgium
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Yvoir
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Bulgaria
State/province [20] 0 0
Plovdiv
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Bulgaria
State/province [21] 0 0
Sofia
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Canada
State/province [22] 0 0
British Columbia
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Canada
State/province [23] 0 0
Manitoba
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Czechia
State/province [25] 0 0
Czech Republic
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France
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Le Mans
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France
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Montpellier
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Germany
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Erlangen
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Germany
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Frankfurt am Main
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Germany
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Gottingen
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Magdeburg
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Germany
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Nienburg
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Italy
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MI
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Italy
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VR
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Italy
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Bologna
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Poland
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Bialystok
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Poland
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Dopiewo
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Poland
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Elblag
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Poland
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Lodz
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Poland
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Poznan
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Russian Federation
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Ekaterinburg
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Russian Federation
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Petrozavodsk
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Russian Federation
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St Petersburg
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Russian Federation
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Yaroslavl
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Sweden
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Stockholm
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United Kingdom
State/province [48] 0 0
London

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 was to provide 16-week efficacy, safety and tolerability data
versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.)
self-administration with or without a loading regimen and maintenance dosing using pre-filled
syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with
active PsA despite current or previous NSAID or DMARD therapy
Trial website
https://clinicaltrials.gov/ct2/show/NCT02294227
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02294227