Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA.

Rheumatoid Arthritis Clinical Trial

— REASSURE-E  

Official title:

A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901900
• Other study ID #: CAIN457F2302E1
• Secondary ID: 2013-000944-25
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2013
• Last updated: August 3, 2016
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaCanada: Health CanadaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosGuatemala: Ministry of Public Health and Social AssistanceIndia: Ministry of HealthMexico: Federal Commission for Sanitary Risks ProtectionThailand: Ministry of Public HealthItaly: The Italian Medicines AgencyHungary: National Institute of PharmacyBelgium: Federal Agency for Medicinal Products and Health ProductsJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This extension study will provide continuing treatment with secukinumab for up to 3 years for subjects who completed the phase III core study, CAIN457F2302. Subjects will be offered maintenance treatment with secukinumab at the 150 mg given subcutaneously every 4 weeks. The study aims to obtain further long term efficacy, safety and tolerability information on secukinumab for patients with rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• 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:

Subjects must give a written informed consent before any assessment is performed.

Subjects must have completed the 104-week treatment period in the core study Subjects who are deemed by the investigator to benefit from continued secukinumab therapy.

Exclusion Criteria:

Use of other investigational drugs except for secukinumab during the core study.

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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).

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Canada	Novartis Investigative Site	Winnipeg	Manitoba
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Eger
Hungary	Novartis Investigative Site	Gyula
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Secunderabad	Andhra Pradesh
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Verona	VR
Japan	Novartis Investigative Site	Chiba-city	Chiba
Japan	Novartis Investigative Site	Fuchu	Tokyo
Japan	Novartis Investigative Site	Fuji-city	Shizuoka
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Hannan-city	Osaka
Japan	Novartis Investigative Site	Hiroshima-city	Hiroshima
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kamakura-city	Kanagawa
Japan	Novartis Investigative Site	Kawachinagano-city	Osaka
Japan	Novartis Investigative Site	Kawagoe	Saitama
Japan	Novartis Investigative Site	Kitakyushu	Fukuoka
Japan	Novartis Investigative Site	Kumamoto-city	Kumamoto
Japan	Novartis Investigative Site	Kurashiki-city	Okayama
Japan	Novartis Investigative Site	Nagano-city	Nagano
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Sagamihara-city	Kanagawa
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sasebo-city	Nagasaki
Japan	Novartis Investigative Site	Shimonoseki-city	Yamaguchi
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Takaoka-city	Toyama
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
Mexico	Novartis Investigative Site	Culiacan	Sinaloa
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Mexicali	Baja California
Mexico	Novartis Investigative Site	Mexicali	Baja California
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Khon Kaen
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Bowling Green	Kentucky
United States	Novartis Investigative Site	Canton	Georgia
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Eagan	Minnesota
United States	Novartis Investigative Site	Greenville	South Carolina
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	Mesquite	Texas
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Paradise Valley	Arizona
United States	Novartis Investigative Site	Peoria	Arizona
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Guatemala,  Hungary,  India,  Italy,  Japan,  Mexico,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacokinetics of secukinumab in serum	Bioanalytical methods to detect secukinumab in serum; trough concentrations (Cmin) and steady state concentrations (ss) will be determined.	every 12 months, and at study completion	No
Primary	Response by American College of Rheumatology response criteria	Improvement in RA signs and symptoms by response criteria established by the American College of Rheumatology (ACR20, ACR50, and ACR70)	every 3 months	No
Secondary	Functional ability and activity restriction measure, HAQ-DI	HAQ-DI includes questions about upper extremities, lower extremities, and activities that involve both. There are 20 questions about difficulty of dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.	every 3 months	No
Secondary	Proportion of patients achieving Major Clinical Response	Major Clinical Response is defined as maintaining an ACR70 response over a continuous six-month period	every 3 months	No
Secondary	RA disease activity as measured by Disease Activity Score (DAS28)	Changes in DAS28 measured on the basis of 28 tender and swollen joint count relative to baseline	every 3 months	No
Secondary	Proportion of subjects achieving Low Disease Activity and good/moderate EULAR responses	Low Disease Activity is defined as DAS28 = 3.2. EULAR good response requires an improvement of > 1.2 in the DAS28 score with a present score of =3.2; EULAR moderate response is defined as an improvement of >0.6 to =1.2 in DAS28 and a present score of =5.1; or an improvement of >1.2 and a present score of >3.2.	every 3 months	No
Secondary	Proportion of subjects achieving ACR/EULAR remission	ACR/EULAR remission is defined as SDAI = 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patient's Global Assessments of Disease	every 3 months	No
Secondary	Changes in individual ACR components relative to baseline	Individual ACR components include: • tender 68-joint count • swollen 66-joint count • Patient's assessment of RA pain • Patient's global assessment of disease activity • Physician's global assessment of disease activity • Acute phase reactant (C-reactive protein or ESR)	every 3 months	No
Secondary	Changes in the van der Heijde total modified Sharp score relative to baseline	The van der Heijde total modified Sharp score enumerates features of joint damage and articular destruction measured from erosions and joint space narrowing observed on X-rays of the hands and feet.	every 12 months	No
Secondary	Changes in quality of life outcomes measured by SF-36 v2, relative to baseline	Short Form Health Survey (SF-36) consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed.	every 12 months	No
Secondary	Safety and tolerability	Treatment emergent adverse events, including serious adverse events will be reported according to their percentages in the trial population and to their incidence per 100 subject years of exposure. Laboratory result and vital signs summaries for the subject population will be reported according to mean values and values outside of normal ranges.	every visit	Yes
Secondary	Development of immunogenicity against secukinumab	Assays to detect anti-secukinumab antibodies	every 12 months, and at study completion	Yes