Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.

Last updated: June 9, 2016
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Rheumatoid Arthritis

Bone Diseases

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT01770379
CAIN457F2311
2011-006058-94
  • Ages > 18
  • All Genders

Study Summary

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.

Eligibility Criteria

Inclusion

Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revisedcriteria for at least 3 months •Disease activity defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive ORRheumatoid Factor positive AND WITH Either hsCRP ≥ 10 mg/L OR ESR ≥28 mm/1st hr •Intake ofat least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab orgolimumab for at least 3 months before entering the study and to have experienced aninadequate response to treatment or to have been intolerant to at least one administration

Exclusion

Exclusion Criteria:

  • Current RA functional status class IV according to the ACR 1991 revised criteria •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17receptor and/or any history of hypersensitivity to secukinumab or its excipient or todrugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteriamay apply

Study Design

Total Participants: 242
Study Start date:
October 01, 2012
Estimated Completion Date:
May 31, 2015

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires B7600FZN
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Salvador de Jujuy, Jujuy Y4600ABF
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Rosario, Santa Fe S2000CXH
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Miguel de Tucuman, Tucuman
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Salvador, BA 40050-410
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Juiz de Fora, MG 36010-570
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Recife, PE 50670-420
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Curitiba, PR 80030-110
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Rio de Janeiro, RJ 20551-030
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 04266-010
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, SP 04266-010
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Bogota, Cundinamarca 001
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Barranquilla,
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Bogotá, 110221
    Colombia

    Site Not Available

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    Bucaramanga,
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Cali,
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Plzen, 301 00
    Czech Republic

    Site Not Available

  • Novartis Investigative Site

    Praha 2, 128 50
    Czech Republic

    Site Not Available

  • Novartis Investigative Site

    Uherske Hradiste, 686 01
    Czech Republic

    Site Not Available

  • Novartis Investigative Site

    Santo Domingo, Republica Dominicana
    Dominican Republic

    Site Not Available

  • Novartis Investigative Site

    Guayaquil, Guayas 412
    Ecuador

    Site Not Available

  • Novartis Investigative Site

    Quito, Pichincha
    Ecuador

    Site Not Available

  • Novartis Investigative Site

    Guayaguil,
    Ecuador

    Site Not Available

  • Novartis Investigative Site

    Bad Doberan, 18209
    Germany

    Site Not Available

  • Novartis Investigative Site

    Donaueschingen, 78166
    Germany

    Site Not Available

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    Dresden, 01109
    Germany

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    Duesseldorf, 40225
    Germany

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    Freiburg, 79106
    Germany

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    Göttingen, 37075
    Germany

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    Halle (Saale), 06128
    Germany

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    Hamburg, 22081
    Germany

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    Hannover, 30625
    Germany

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    Hildesheim, 31134
    Germany

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    Magdeburg, 39110
    Germany

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    Pirna, 01796
    Germany

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    Ratingen, 40882
    Germany

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    Zerbst, 39261
    Germany

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    Athens, GR 115 27
    Greece

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    Heraklion, GR 700 13
    Greece

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    Guatemala City, 01010
    Guatemala

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    Hyderabad, Andhra Pradesh 500082
    India

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    Secunderabad, Andhra Pradesh 500003
    India

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    New Delhi, Delhi 110 060
    India

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    Pune, Maharashtra 411 040
    India

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    Ajmer, Rajasthan 305001
    India

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    Jaipur, Rajasthan 302013
    India

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    Bergamo, BG 24128
    Italy

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    Catania, CT 95100
    Italy

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    Roma, RM 00152
    Italy

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    Valeggio Sul Mincio, VR 37067
    Italy

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    Verona, VR 37100
    Italy

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    Bologna, 40138
    Italy

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    Fukuoka-city, Fukuoka 813-0017
    Japan

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    Takasaki-city, Gunma 370-0053
    Japan

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    Hiroshima-city, Hiroshima 733-0032
    Japan

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    Yokohama-city, Kanagawa 230-0023
    Japan

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  • Novartis Investigative Site

    Kumamoto-city, Kumamoto 862-0976
    Japan

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    Miyagi-gun, Miyagi 981-0112
    Japan

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  • Novartis Investigative Site

    Nagano-city, Nagano 380-8582
    Japan

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  • Novartis Investigative Site

    Sasebo-city, Nagasaki 857-1165
    Japan

    Site Not Available

  • Novartis Investigative Site

    Setouchi-city, Okayama 701-4264
    Japan

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    Kawachinagano-city, Osaka 586-8521
    Japan

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    Tokorozawa-city, Saitama 359-1111
    Japan

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    Hamamatsu-city, Shizuoka 430-8558
    Japan

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    Toyama-city, Toyama 930-0138
    Japan

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    Anyang, Gyeonggi-do 431-070
    Korea, Republic of

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    Seoul, Korea 03080
    Korea, Republic of

    Site Not Available

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    Panama City, Panamá 0823-01510
    Panama

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  • Novartis Investigative Site

    Lisboa, 1600-190
    Portugal

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    Porto, 4200-319
    Portugal

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    San Juan, 00909
    Puerto Rico

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    Panorama, Western Cape 7500
    South Africa

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    Durban, 4001
    South Africa

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  • Novartis Investigative Site

    Pretoria, 0002
    South Africa

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  • Novartis Investigative Site

    Anniston, Alabama 36207-5710
    United States

    Site Not Available

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    Peoria, Arizona 85381
    United States

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    Tucson, Arizona 85712
    United States

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    Pismo Beach, California 93449
    United States

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  • Novartis Investigative Site

    Santa Barbara, California 93108
    United States

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  • Novartis Investigative Site

    Santa Monica, California 90404
    United States

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  • Novartis Investigative Site

    Upland, California 91786
    United States

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  • Novartis Investigative Site

    Westlake Village, California 91361
    United States

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  • Novartis Investigative Site

    Hamden, Connecticut 06518
    United States

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  • Novartis Investigative Site

    Miami, Florida 33135
    United States

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  • Novartis Investigative Site

    Pembroke Pines, Florida 33026
    United States

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  • Novartis Investigative Site

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Novartis Investigative Site

    Cumberland, Maryland 21502
    United States

    Site Not Available

  • Novartis Investigative Site

    Frederick, Maryland 21702
    United States

    Site Not Available

  • Novartis Investigative Site

    Chaska, Minnesota 55318
    United States

    Site Not Available

  • Novartis Investigative Site

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Novartis Investigative Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Novartis Investigative Site

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Novartis Investigative Site

    Lees Summit, Missouri 64086
    United States

    Site Not Available

  • Novartis Investigative Site

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Novartis Investigative Site

    Omaha, Nebraska 68114
    United States

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  • Novartis Investigative Site

    Reno, Nevada 89502
    United States

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  • Novartis Investigative Site

    Albuquerque, New Mexico 87102
    United States

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  • Novartis Investigative Site

    Binghamton, New York 13905
    United States

    Site Not Available

  • Novartis Investigative Site

    Brooklyn, New York 11201
    United States

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  • Novartis Investigative Site

    Zanesville, Ohio 43701
    United States

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  • Novartis Investigative Site

    Oklahoma City, Oklahoma 73134
    United States

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  • Novartis Investigative Site

    Charleston, South Carolina 29406
    United States

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  • Novartis Investigative Site

    North Charleston, South Carolina 29406
    United States

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  • Novartis Investigative Site

    Rapid City, South Dakota 57701
    United States

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  • Novartis Investigative Site

    Jackson, Tennessee 38305
    United States

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  • Novartis Investigative Site

    Nashville, Tennessee 37203-1424
    United States

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    Amarillo, Texas 79124
    United States

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    Benbrook, Texas 76126
    United States

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    Houston, Texas 77005
    United States

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    Mesquite, Texas 75150
    United States

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  • Novartis Investigative Site

    Tacoma, Washington 98405
    United States

    Site Not Available

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