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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01392326
Ethics application status
Date submitted
7/07/2011
Date registered
11/07/2011
Date last updated
5/01/2016

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 - A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)
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 - A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis
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 - A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg - DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 ("0":no activity, "100": highest activity possible)
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg - The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg - HAQ-DI, assesses a patient's 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 extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week "Are you able to …" perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled).
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 - ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.
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) - Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
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
Gender
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
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)
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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California
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Florida
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United States of America
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Georgia
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United States of America
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Massachusetts
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United States of America
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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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United States of America
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New Jersey
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North Carolina
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United States of America
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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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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Pleven
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Bulgaria
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Sevlievo
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Bulgaria
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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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Germany
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Hildesheim
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Germany
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Koeln
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Germany
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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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Ashkelon
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Haifa
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Israel
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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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Italy
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SI
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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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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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Kemerovo
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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
This study will assess the efficacy and safety of secukinumab in patients with active
psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs,
DMARDs and / or TNFa inhibitor therapy.
Trial website
https://clinicaltrials.gov/show/NCT01392326
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