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)

Last updated: January 5, 2016
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Psoriatic Arthritis

Arthritis And Arthritic Pain

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT01392326
CAIN457F2306
2011-000276-34
  • Ages > 18
  • All Genders

Study 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 TNFα inhibitor therapy.

Eligibility Criteria

Inclusion

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 monthswith 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 ≥2cmdiameter or nail changes consistent with psoriasis or documented history o plaquepsoriasis

Exclusion

Exclusion criteria:

  • Chest X-ray with evidence of ongoing infectious or malignant process

  • Subjects who have previously been treated with more than 3 different TNFα inhibitors

  • Subjects taking high potency opioid analgesics

  • Subjects who have ever received biologic immunomodulating agents except for thosetargeting TNFα Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 606
Study Start date:
September 01, 2011
Estimated Completion Date:
October 31, 2014

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires C1181ACH
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Rosario, Santa Fe S2000CFJ
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Buenos Aires, C1417EYG
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Capital Federal,
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Cordoba, X5016KEH
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Maroochydore, Queensland 4558
    Australia

    Site Not Available

  • Novartis Investigative Site

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Novartis Investigative Site

    Daw Park,
    Australia

    Site Not Available

  • Novartis Investigative Site

    Bruxelles,
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Genk, 3600
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Gent, 9000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Porto Alegre, RS 90610-000
    Brazil

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    Sao Paulo, SP 04266-010
    Brazil

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    São Paulo, SP 04023-900
    Brazil

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    Pleven, 5800
    Bulgaria

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    Sevlievo, 5400
    Bulgaria

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    Sofia, 1612
    Bulgaria

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    Varna,
    Bulgaria

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    St. John, Newfoundland and Labrador A1B 5E8
    Canada

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    St. John's, Newfoundland and Labrador A1C 5B8
    Canada

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    Courtice, Ontario
    Canada

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    Newmarket, Ontario L3Y 3R7
    Canada

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    Waterloo, Ontario N2J 1C4
    Canada

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    Trois-Rivieres, Quebec G8Z 1Y2
    Canada

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    Bogota,
    Colombia

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    Bruntal, 792 01
    Czech Republic

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    Kutna Hora,
    Czech Republic

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    Uherske Hradiste, 686 01
    Czech Republic

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    Zlin, 760 01
    Czech Republic

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    Aachen, 52064
    Germany

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    Berlin, 12203
    Germany

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    Erlangen, 91054
    Germany

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    Frankfurt am Main,
    Germany

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    Gommern, 39245
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    Großhansdorf,
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    Großhansdorf,
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    Hamburg, 22415
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    Herne, 44649
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    Hildesheim, 31134
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    Koeln, 50924
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    Leipzig, 04103
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    Ratingen, 40882
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    Zerbst, 39261
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    Ashkelon, 78278
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    Haifa, 3339419
    Israel

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    Petach-Tikva,
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    Ramat Gan, 5266202
    Israel

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    Tel-Aviv, 6423906
    Israel

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    Zrifin, 70300
    Israel

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    Valeggio Sul Mincio, (vr) 37067
    Italy

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    Catania, CT 95100
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    Prato, PO 59100
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    Siena, SI 53100
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    Montecchio Maggiore,
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    Lima,
    Peru

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    Lipa City, Batangas 4217
    Philippines

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    Dasmarinas, Cavite 4114
    Philippines

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    Bulacan,
    Philippines

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    Las Pinas, 1740
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    Manila, 1008
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    Quezon City, 1121
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    Bialystok, 15-351
    Poland

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    Warszawa, 02-341
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    Bucharest,
    Romania

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    Cluj Napoca, 400006
    Romania

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    Iasi, 700195
    Romania

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    Barnaul,
    Russian Federation

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    Ekaterinburg, 620102
    Russian Federation

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    Kemerovo, 650029
    Russian Federation

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    Moscow, 115522
    Russian Federation

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    St-Petersburg, 190068
    Russian Federation

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    Yaroslavl, 150003
    Russian Federation

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    Singapore, 169608
    Singapore

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    Piestany, Slovak Republic 921 12
    Slovakia

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    Bardejov,
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    Lucenec, 98401
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    Kaohsiung,
    Taiwan

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    Bangkok, 10400
    Thailand

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    Chiang Mai, 50200
    Thailand

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    Khon Kaen, 40002
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    Mersin,
    Turkey

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    Cannock, Staffordshire WS11 2XY
    United Kingdom

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    Bradford, West Yorkshire BD5 0NA
    United Kingdom

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    Glasgow, G12 8TA
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    London, SE1 9RT
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    Anniston, Alabama 36207-5710
    United States

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    Newnan, Georgia 30263
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    Boston, Massachusetts 02111
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    Eagan, Minnesota 55121
    United States

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    Richmond Heights, Missouri 63117
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    Lincoln, Nebraska 68516
    United States

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    Freehold, New Jersey 07728
    United States

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    Charlotte, North Carolina 28210
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    Oklahoma City, Oklahoma 73103
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    Duncansville, Pennsylvania 16635
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    Mesquite, Texas 75150
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    Seattle, Washington 98122
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