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

Rheumatoid Arthritis Clinical Trial

— REASSURE2  

Official title:

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770379
• Other study ID #: CAIN457F2311
• Secondary ID: 2011-006058-94
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2012
• Last updated: December 14, 2015
• Start date: October 2012
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaRepublic of Korea: Ministry of Food and Drug Safety (MFDS)Brazil: National Health Surveillance AgencyColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlGermany: Paul-Ehrlich-InstitutGuatemala: Ministry of Public Health and Social AssistanceIndia: Ministry of HealthPanama: Ministry of HealthDominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)Ecuador: Public Health MinistryGreece: National Organization of MedicinesIndia: Drugs Controller General of IndiaItaly: The Italian Medicines AgencyJapan: Pharmaceuticals and Medical Devices AgencyPortugal: National Pharmacy and Medicines InstituteSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria 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 OR Rheumatoid Factor positive AND WITH Either hsCRP = 10 mg/L OR ESR =28 mm/1st hr •Intake of at least one anti-TNF-a agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration 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-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Juiz de Fora	MG
Brazil	Novartis Investigative Site	Salvador	BA
Brazil	Novartis Investigative Site	Sao Paulo	SP
Colombia	Novartis Investigative Site	Bogotá
Colombia	Novartis Investigative Site	Cali
Czech Republic	Novartis Investigative Site	Praha 2
Czech Republic	Novartis Investigative Site	Uherske Hradiste
Dominican Republic	Novartis Investigative Site	Santo Domingo	Republica Dominicana
Germany	Novartis Investigative Site	Bad Doberan
Germany	Novartis Investigative Site	Göttingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Pirna
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Heraklion	GR
Guatemala	Novartis Investigative Site	Guatemala City
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	New Delhi	Delhi
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Secunderabad	Andhra Pradesh
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Verona	VR
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Hiroshima-city	Hiroshima
Japan	Novartis Investigative Site	Kawachinagano-city	Osaka
Japan	Novartis Investigative Site	Kumamoto-city	Kumamoto
Japan	Novartis Investigative Site	Miyagi-gun	Miyagi
Japan	Novartis Investigative Site	Nagano-city	Nagano
Japan	Novartis Investigative Site	Sasebo-city	Nagasaki
Japan	Novartis Investigative Site	Setouchi-city	Okayama
Japan	Novartis Investigative Site	Takasaki-city	Gunma
Japan	Novartis Investigative Site	Tokorozawa-city	Saitama
Japan	Novartis Investigative Site	Toyama-city	Toyama
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Panama	Novartis Investigative Site	Panama City	Panamá
Panama	Novartis Investigative Site	Panama City	Panamá
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
South Africa	Novartis Investigative Site	Panorama	Western Cape
United States	Novartis Investigative Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Amarillo	Texas
United States	Novartis Investigative Site	Benbrook	Texas
United States	Novartis Investigative Site	Cumberland	Maryland
United States	Novartis Investigative Site	Edina	Minnesota
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Jackson	Tennessee
United States	Novartis Investigative Site	Lees Summit	Missouri
United States	Novartis Investigative Site	Mesquite	Texas
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	North Charleston	South Carolina
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Pembroke Pines	Florida
United States	Novartis Investigative Site	Peoria	Arizona
United States	Novartis Investigative Site	Rapid City	South Dakota
United States	Novartis Investigative Site	Reno	Nevada
United States	Novartis Investigative Site	Santa Monica	California
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Tupelo	Mississippi
United States	Novartis Investigative Site	Upland	California
United States	Novartis Investigative Site	Zanesville	Ohio
United States	Novartis Investigative Site	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Colombia,  Czech Republic,  Dominican Republic,  Germany,  Greece,  Guatemala,  India,  Italy,  Japan,  Korea, Republic of,  Panama,  Portugal,  South Africa, 

Outcome

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