Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 1 Year of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents.

Rheumatoid Arthritis Clinical Trial

— NURTURE 1  

Official title:

A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents

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

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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