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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01392326




Registration number
NCT01392326
Ethics application status
Date submitted
7/07/2011
Date registered
12/07/2011
Date last updated
4/02/2016

Titles & IDs
Public title
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis
Secondary ID [1] 0 0
2011-000276-34
Secondary ID [2] 0 0
CAIN457F2306
Universal Trial Number (UTN)
Trial acronym
FUTURE 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
Treatment: Drugs - Secukinumab (75 mg)
Treatment: Drugs - Secukinumab (150 mg)
Treatment: Drugs - Placebo Comparator

Experimental: Group 1 - Secukinumab (75mg)

Experimental: Group 2 - Secukinumab (150 mg)

Placebo comparator: Group 3 -


Treatment: Drugs: Secukinumab (75 mg)
Secukinumab (75 mg)

Treatment: Drugs: Secukinumab (150 mg)
Secukinumab (150 mg)

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

Outcomes
Primary outcome [1] 0 0
Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have =3% Skin Involvement With Psoriasis at Baseline
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have =3% Skin Involvement With Psoriasis at Baseline
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline
Timepoint [9] 0 0
Week 24

Eligibility
Key inclusion criteria
Inclusion criteria:

* Male or non-pregnant, non-lactating female patients at least 18 years of age
* 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
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Chest X-ray with evidence of ongoing infectious or malignant process
* Subjects who have previously been treated with more than 3 different TNFa inhibitors
* Subjects taking high potency opioid analgesics
* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa 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
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
606
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
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
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Florida
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United States of America
State/province [5] 0 0
Georgia
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United States of America
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Massachusetts
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Minnesota
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United States of America
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Missouri
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United States of America
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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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Rhode Island
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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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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Cordoba
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Leuven
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RS
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Brazil
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SP
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Pleven
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Sevlievo
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Sofia
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Bruntal
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Czech Republic
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Uherske Hradiste
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Czech Republic
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Zlin
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Gommern
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Germany
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Hamburg
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Germany
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Herne
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Hildesheim
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Germany
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Koeln
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Leipzig
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Germany
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Nürnberg
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Germany
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Ratingen
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Germany
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Zerbst
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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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(vr)
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Italy
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CT
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Italy
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PO
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SI
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Batangas
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Cavite
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Las Pinas
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Manila
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Quezon City
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Poland
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Bialystok
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Poland
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Warszawa
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Romania
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District 1
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Iasi
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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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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Singapore
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Singapore
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Slovakia
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Slovak Republic
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Slovakia
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Lucenec
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Thailand
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Bangkok
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Chiang Mai
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Khon Kaen
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England
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Staffordshire
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West Yorkshire
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Glasgow
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01392326