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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/NCT01892436




Registration number
NCT01892436
Ethics application status
Date submitted
1/07/2013
Date registered
4/07/2013
Date last updated
12/06/2019

Titles & IDs
Public title
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Scientific title
A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
Secondary ID [1] 0 0
2013-001241-13
Secondary ID [2] 0 0
CAIN457F2306E1
Universal Trial Number (UTN)
Trial acronym
FUTURE 1 ext
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
Treatment: Drugs - Secukinumab
Treatment: Drugs - Placebo

Experimental: Secukinumab 75mg - Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator

Experimental: Secukinumab 150mg - Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator

Experimental: Placebo - AIN457A 75mg - Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg

Experimental: Placebo - AIN457 150mg - Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg


Treatment: Drugs: Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Timepoint [1] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Primary outcome [2] 0 0
Proportion of Subjects Who Reached ACR50
Timepoint [2] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Primary outcome [3] 0 0
Proportion of Subjects Who Reached ACR70
Timepoint [3] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [1] 0 0
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Timepoint [1] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [2] 0 0
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
Timepoint [2] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [3] 0 0
Change From Baseline in Disease Activity Score-CRP (DAS28)
Timepoint [3] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [4] 0 0
Percentage of Subjects Achieving Low Disease Activity
Timepoint [4] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Secondary outcome [5] 0 0
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
Timepoint [5] 0 0
weeks 116, 128, 140, 156, 180, 208, 232 and 260

Eligibility
Key inclusion criteria
Inclusion criteria

- Subjects must be able to understand and communicate with the investigator and comply
with the requirements of the study and must give a written, signed and dated informed
consent before any study assessment is performed

- Subjects must have participated in core study CAIN457F2306, and must have completed
the entire treatment period

- Subjects must be deemed by the investigator to benefit from continued secukinumab
therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

- Any subject taking other concomitant biologic immunomodulating agent(s) except
secukinumab

- Any subject who is deemed not to be benefiting from the study treatment based upon
lack of improvement or worsening of their symptoms

- Pregnant or nursing (lactating) women

- Women of child-bearing potential, unless they are using effective methods of
contraception during the entire study or longer if required by locally approved
prescribing information (e.g., 20 weeks in EU)

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 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
30/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/01/2018
Sample size
Target
Accrual to date
Final
460
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [2] 0 0
Novartis Investigative Site - Malvern East
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
3145 - Malvern East
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Minnesota
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Missouri
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Nebraska
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New Jersey
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North Carolina
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Washington
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Buenos Aires
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Santa Fe
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Argentina
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Caba
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Cordoba
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Córdoba
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Belgium
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Genk
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Belgium
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Gent
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Leuven
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Brazil
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Rio Grande Do Sul
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Brazil
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SP
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Bulgaria
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Gabrovo
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Pleven
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Sofia
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Czech Republic
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Aachen
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Gommern
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Haifa
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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CT
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Italy
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PO
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Italy
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SI
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Italy
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VR
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Batangas
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Cavite
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Metro Manila
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Las Pinas
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Manila
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Quezon City
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Bialystok
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Warszawa
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Russian Federation
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Ekaterinburg
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Kemerovo
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Moscow
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St Petersburg
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Singapore
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Singapore
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Lucenec
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THA
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Thailand
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Bangkok
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Chiang Mai
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United Kingdom
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London
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Staffordshire
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West Yorkshire
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United Kingdom
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Glasgow

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

Ethics approval
Ethics application status

Summary
Brief summary
This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It
aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for
subjects who completed the core study CAIN457F2306, to obtain further long term efficacy,
safety and tolerability information in subjects with active psoriatic arthritis receiving
secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed
the assessments associated with the core study visit and subsequently continued in this
extension study on the same dose that they were receiving during the core study. The regular
assessments of disease activity ensure that subjects who are experienced worsening of disease
in any of the treatment groups could exit the study upon their own wish or based on the
advice of the investigator at any time.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01892436
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/NCT01892436