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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01350804
Other study ID # CAIN457F2309
Secondary ID 2011-000102-21
Status Completed
Phase Phase 3
First received May 9, 2011
Last updated October 29, 2015
Start date September 2011
Est. completion date February 2015

Study information

Verified date October 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Bulgarian Drug AgencyBrazil: National Health Surveillance AgencyCanada: Health CanadaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlGermany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyMexico: Federal Commission for Sanitary Risks ProtectionRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSpain: Agencia Española de Medicamentos y Productos SanitariosUnited States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: The Italian Medicines AgencySlovakia: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.


Other known NCT identifiers
  • NCT01640938

Recruitment information / eligibility

Status Completed
Enrollment 551
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or non-pregnant, non-lactating female patients

- Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening

- At Baseline: Disease activity criteria defined by >= 6 tender joints out of 68 and >= 6 swollen joints out of 66

WITH at least 1 of the following at screening:

- Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR

- Rheumatoid Factor positive

AND WITH at least 1 of the following at screening:

- High sensitivity C-Reactive Protein (hsCRP) >= 10 mg/L OR

- Erythrocyte Sedimentation Rate (ESR) >= 28 millimeter (mm)/1st hour

- Patients must have been taking at least one anti-TNF-a agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-a agent

- Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated dose)

Exclusion Criteria:

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

- RA patients functional status class IV according to the ACR 1991 revised criteria

- Patients who have ever received biologic immunomodulating agents except for those targeting TNFa

- Previous treatment with any cell-depleting therapies

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Placebo

Abatacept


Locations

Country Name City State
Brazil Novartis Investigative Site Curitiba PR
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site Rio de Janeiro RJ
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site São Paulo SP
Bulgaria Novartis Investigative Site Plovdiv
Bulgaria Novartis Investigative Site Plovdiv
Bulgaria Novartis Investigative Site Russe
Bulgaria Novartis Investigative Site Sevlievo
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Sofia
Bulgaria Novartis Investigative Site Sofia
Canada Novartis Investigative Site Sainte-Foy Quebec
Canada Novartis Investigative Site St. John's Newfoundland and Labrador
Canada Novartis Investigative Site Trois-Rivieres Quebec
Colombia Novartis Investigative Site Barranquilla
Colombia Novartis Investigative Site Bogotá
Colombia Novartis Investigative Site Bogotá Cundinamarca
Czech Republic Novartis Investigative Site Bruntal
Czech Republic Novartis Investigative Site Ostrava
Czech Republic Novartis Investigative Site Uherske Hradiste
Czech Republic Novartis Investigative Site Zlin
France Novartis Investigative Site Bordeaux Cedex
France Novartis Investigative Site Cahors
France Novartis Investigative Site Montpellier
France Novartis Investigative Site Paris
France Novartis Investigative Site Toulouse
Germany Novartis Investigative Site Aachen
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Cottbus
Germany Novartis Investigative Site Erlangen
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Gommern
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Koeln
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Osnabrück
Germany Novartis Investigative Site Zerbst
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Gyor
Hungary Novartis Investigative Site Gyula
Hungary Novartis Investigative Site Szolnok
Italy Novartis Investigative Site Firenze FI
Italy Novartis Investigative Site Genova GE
Italy Novartis Investigative Site Perugia PG
Italy Novartis Investigative Site Siena SI
Italy Novartis Investigative Site Valeggio Sul Mincio (vr)
Mexico Novartis Investigative Site Culiacan Sinaloa
Mexico Novartis Investigative Site Guadalajara Jalisco
Mexico Novartis Investigative Site Mexicali Baja California
Mexico Novartis Investigative Site Mexico Distrito Federal
Mexico Novartis Investigative Site Mexico Distrito Federal
Mexico Novartis Investigative Site Monterrey Nuevo León
Romania Novartis Investigative Site Iasi
Russian Federation Novartis Investigative Site Korolev
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Petrozavodsk
Russian Federation Novartis Investigative Site Saint-Petersburg
Russian Federation Novartis Investigative Site Tula
Slovakia Novartis Investigative Site Banska Bystrica Slovak Republic
Slovakia Novartis Investigative Site Piestany
Spain Novartis Investigative Site La Coruna Galicia
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Malaga Andalucia
Spain Novartis Investigative Site Sabadell Barcelona
Spain Novartis Investigative Site Santander Cantabria
Spain Novartis Investigative Site Santiago de Compostela Galicia
Spain Novartis Investigative Site Sevilla Andalucia
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Aventura Florida
United States Novartis Investigative Site Boca Raton Florida
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Bowling Green Kentucky
United States Novartis Investigative Site Bridgeport Connecticut
United States Novartis Investigative Site Carrollton Texas
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Clarksburg West Virginia
United States Novartis Investigative Site Coeur d'Alene Idaho
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Eagan Minnesota
United States Novartis Investigative Site Freemont California
United States Novartis Investigative Site Hialeah Florida
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Jackson Tennessee
United States Novartis Investigative Site Kansas City Missouri
United States Novartis Investigative Site Kingsport Tennessee
United States Novartis Investigative Site Lansing Michigan
United States Novartis Investigative Site Lexington Kentucky
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site Morton Grove Illinois
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Orlando Florida
United States Novartis Investigative Site Palm Harbor Florida
United States Novartis Investigative Site Pembroke Pines Florida
United States Novartis Investigative Site Pensacola Florida
United States Novartis Investigative Site Plantation Florida
United States Novartis Investigative Site Pomona California
United States Novartis Investigative Site Richmond Heights Missouri
United States Novartis Investigative Site Sarasota Florida
United States Novartis Investigative Site Spokane Washington
United States Novartis Investigative Site Springfield Illinois
United States Novartis Investigative Site Sugar Land Texas
United States Novartis Investigative Site Tampa Florida
United States Novartis Investigative Site Upland California
United States Novartis Investigative Site Van Nuys California
United States Novartis Investigative Site Vestavia Alabama
United States Novartis Investigative Site Waco Texas
United States Novartis Investigative Site Wichita Kansas
United States Novartis Investigative Site Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Brazil,  Bulgaria,  Canada,  Colombia,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Mexico,  Romania,  Russian Federation,  Slovakia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab (AIN457) compared to placebo week 24 No
Secondary First key (ranked) secondary objective: Disease Activity Score utilizing CRP (DAS28-CRP) To demonstrate that the efficacy of secukinumab is superior to placebo with respect to change from baseline in DAS28-CRP week 24 No
Secondary Second key (ranked) secondary objective: Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) To demonstrate that the efficacy of secukinumab is superior to placebo with respect to the change from baseline in HAQ-DI week 24 No
Secondary Final key (ranked) secondary objective: ACR50 responder rate To demonstrate that the efficacy of secukinumab is superior to placebo based on the proportion of subjects achieving an ACR50 response week 24 No
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