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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/NCT01752634




Registration number
NCT01752634
Ethics application status
Date submitted
23/10/2012
Date registered
19/12/2012
Date last updated
13/05/2020

Titles & IDs
Public title
Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis
Scientific title
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis
Secondary ID [1] 0 0
2012-004439-22
Secondary ID [2] 0 0
CAIN457F2312
Universal Trial Number (UTN)
Trial acronym
FUTURE 2
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 (AIN457)
Treatment: Drugs - Placebo

Experimental: Secukinumab (AIN457) 75 mg s.c. - Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.

Experimental: Secukinumab (AIN457) 150 mg s.c. - Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.

Experimental: Secukinumab (AIN457) 300 mg s.c. - Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4

Placebo Comparator: Placebo s.c. - Placebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. Non-responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 16. Responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 24.


Treatment: Drugs: Secukinumab (AIN457)
Secukinumab (AIN457)

Treatment: Drugs: Placebo
Placebo PFS for s.c. administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have =3% Skin Involvement With Psoriasis
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have =3% Skin Involvement With Psoriasis
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in DAS28-CRP
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change From Baseline in SF36-Physical Component Score
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Number of Participants Achieving American College of Rheumatology 50 (ACR50) Response Criteria
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Number of Participants With Dactylitis in the Subset of Subjects Who Had Dactylitis at Baseline
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Number of Participants With Enthesitis in the Subset of Subjects Who Had Enthesitis at Baseline
Timepoint [8] 0 0
Week 24

Eligibility
Key inclusion criteria
Patients eligible for inclusion in this study have to fulfill all of the
following criteria:

- Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months
with moderate to severe PsA who must have at Baseline =3 tender joints out of 78 and
=3 swollen out of 76 (dactylitis of a digit counts as one joint each)

- Rheumatoid factor and anti-CCP antibodies negative at screening

- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or
documented history of plaque psoriasis

- Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization
with inadequate control of symptoms or at least one dose if stopped due to intolerance
to NSAIDs

- Subjects taking corticosteroids must be on a stable dose of =10 mg/day prednisone or
equivalent for at least 2 weeks before randomization and should remain on a stable
dose up to Week 24

- Subjects taking MTX (= 25 mg/week) are allowed to continue their medication if the
dose is stable for at least 4 weeks before randomization and should remain on a stable
dose up to Week 52.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients fulfilling any of the following criteria are not eligible for
inclusion in this study:

- Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process,
obtained within 3 months prior to screening and evaluated by a qualified physician

- Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone,
morphine)

- Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or
IL-17 receptor

- Ongoing use of prohibited psoriasis treatments / medications (e.g., topical
corticosteroids, UV therapy) at randomization. The following wash out periods need to
be observed:

- Oral or topical retinoids 4 weeks

- Photochemotherapy (e.g. PUVA) 4 weeks

- Phototherapy (UVA or UVB) 2 weeks

- Topical skin treatments (except in face, scalp and genital area during screening, only
corticosteroids with mild to moderate potency) 2 weeks

- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFa, investigational or approved

- Previous treatment with any cell-depleting therapies including but not limited to
anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3,
anti-CD19)

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 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
14/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2019
Sample size
Target
Accrual to date
Final
397
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Genk
Country [12] 0 0
Belgium
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Hasselt
Country [13] 0 0
Belgium
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Leuven
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Canada
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Manitoba
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Canada
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Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Czechia
State/province [17] 0 0
Czech Republic
Country [18] 0 0
Czechia
State/province [18] 0 0
Prague 2
Country [19] 0 0
Czechia
State/province [19] 0 0
Uherske Hradiste
Country [20] 0 0
Germany
State/province [20] 0 0
Aachen
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Erlangen
Country [23] 0 0
Germany
State/province [23] 0 0
Germering
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Germany
State/province [24] 0 0
Hamburg
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Germany
State/province [25] 0 0
Herne
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Germany
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Wuerzburg
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Germany
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Zerbst
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Poland
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Lodz
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Poland
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Poznan
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Poland
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Warszawa
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Poland
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Wroclaw
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Puerto Rico
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Ponce
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Petrozavodsk
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Russian Federation
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Rostov on Don
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Russian Federation
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Sestroretsk
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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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Thailand
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Bangkok
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United Kingdom
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England
Country [44] 0 0
United Kingdom
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Manchester
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United Kingdom
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Staffordshire
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United Kingdom
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Surrey
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United Kingdom
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West Midlands
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United Kingdom
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West Yorkshire
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United Kingdom
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Blackpool
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
State/province [53] 0 0
Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the
registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self
administration in subjects with active PsA despite current or previous NSAID, DMARD and/or
anti-TNFa therapy. An additional 4 years of long-term efficacy and safety data were collected
during the post Week 52 period of the study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01752634
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