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Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents (REASSURE)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Secukinumab (AIN457)

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, ACR, inflammatory joints

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Male or non-pregnant, non-lactating female patients
Presence of RA classified by American College of Rheumatology (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 (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 mm/1st hr
Patients must have been taking at least one anti-TNF-α 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-α agent
Patients must be taking MTX 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 Japan only: 6 to 25 mg/week)

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 TNFα
Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
Other protocol-defined inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

AIN457 10mg/kg-75mg

AIN457 10mg/kg-150mg

Placebo

Arm Description

Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks

Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks

Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24

Outcomes

Primary Outcome Measures

Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24

ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.

Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70

Secondary Outcome Measures

Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.

Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score

Separate radiographs of each hand/wrist and each foot were taken at basline and Week 24. The radiographs were assessed using the van der Heijde modified Sharp score. The change in the Van der Heijde modified Sharp score is calculated against the baseline value. The total van der Heide modified Sharp score goes from 0 to 448, the bigger the change, the worse it is for the patient.

Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52

The major clinical response is defined as continuous six-month period of ACR70 response during the 1 year period. ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR70 response results at week 24 used non-responder imputation.

Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28)

The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health. Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6.

Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (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.

Extension Phase: 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

Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2

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.

Extension Phase: Immunogenicity Against Secukinumab

Full Information

NCT ID

NCT01377012

First Posted

June 17, 2011

Last Updated

February 9, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01377012

Brief Title

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents

Acronym

REASSURE

Official Title

A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

August 30, 2011 (Actual)

Primary Completion Date

September 9, 2015 (Actual)

Study Completion Date

September 9, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The core and extension studies assessed 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. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.

Detailed Description

CAIN457F2302 (Core Study): Completed Sep 9 2015 CAIN457F2302E1 (Extension study): terminated early May 26 2015, ((unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, RA, ACR, inflammatory joints

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

637 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIN457 10mg/kg-75mg

Arm Type

Experimental

Arm Description

Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks

Arm Title

AIN457 10mg/kg-150mg

Arm Type

Experimental

Arm Description

Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Secukinumab (AIN457)

Other Intervention Name(s)

AIN457

Intervention Description

AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.

Primary Outcome Measure Information:

Title

Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24

Description

Time Frame

Week 24

Title

Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70

Time Frame

up to week 260

Secondary Outcome Measure Information:

Title

Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

Description

Time Frame

Baseline, Week 24

Title

Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score

Description

Time Frame

Week 24

Title

Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52

Description

Time Frame

52 week

Title

Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28)

Description

Time Frame

week 260

Title

Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses

Description

Time Frame

up to week 260

Title

Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission

Description

Time Frame

up to week 260

Title

Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2

Description

Time Frame

Baseline, up to week 260

Title

Extension Phase: Immunogenicity Against Secukinumab

Time Frame

up to week 260

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Male or non-pregnant, non-lactating female patients Presence of RA classified by American College of Rheumatology (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 (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 mm/1st hr Patients must have been taking at least one anti-TNF-α 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-α agent Patients must be taking MTX 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 Japan only: 6 to 25 mg/week) 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 TNFα Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19) Other protocol-defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Novartis Investigative Site

City

Paradise Valley

State/Province

Arizona

ZIP/Postal Code

85253

Country

United States

Facility Name

Novartis Investigative Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Novartis Investigative Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Novartis Investigative Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Novartis Investigative Site

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Novartis Investigative Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Novartis Investigative Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Novartis Investigative Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Novartis Investigative Site

City

Largo

State/Province

Florida

ZIP/Postal Code

33773

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Novartis Investigative Site

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Novartis Investigative Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Novartis Investigative Site

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614-7118

Country

United States

Facility Name

Novartis Investigative Site

City

Canton

State/Province

Georgia

ZIP/Postal Code

30114

Country

United States

Facility Name

Novartis Investigative Site

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Novartis Investigative Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Novartis Investigative Site

City

Eagan

State/Province

Minnesota

ZIP/Postal Code

55121

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

66160-7330

Country

United States

Facility Name

Novartis Investigative Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Novartis Investigative Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Novartis Investigative Site

City

Gallipolis

State/Province

Ohio

ZIP/Postal Code

45631

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15237

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Novartis Investigative Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Novartis Investigative Site

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37604

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Novartis Investigative Site

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Lanus

State/Province

Buenos Aires

ZIP/Postal Code

B8000XAV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000CFJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S200BHD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1114AAP

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1417EYG

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

ZIP/Postal Code

C1419AHN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

ZIP/Postal Code

C1428AZF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Novartis Investigative Site

City

St. Catharines

State/Province

Ontario

ZIP/Postal Code

L2N 7E4

Country

Canada

Facility Name

Novartis Investigative Site

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1v 3M7

Country

Canada

Facility Name

Novartis Investigative Site

City

Bogotá

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bucaramanga

Country

Colombia

Facility Name

Novartis Investigative Site

City

Medellín

Country

Colombia

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01015

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekesfehervar

ZIP/Postal Code

H-8000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

H-8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500004

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110 060

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560043

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

Country

India

Facility Name

Novartis Investigative Site

City

Amravati

State/Province

Maharashtra

ZIP/Postal Code

444606

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 053

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411 007

Country

India

Facility Name

Novartis Investigative Site

City

Ajmer

State/Province

Rajasthan

ZIP/Postal Code

305 001

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

320013

Country

India

Facility Name

Novartis Investigative Site

City

Secunderabad

State/Province

Telangana

ZIP/Postal Code

500003

Country

India

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95100

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Pieve di Coriano

State/Province

ZIP/Postal Code

46020

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Chiba-city

State/Province

Chiba

ZIP/Postal Code

260-0801

Country

Japan

Facility Name

Novartis Investigative Site

City

Yotsukaido-city

State/Province

Chiba

ZIP/Postal Code

284-0003

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka-city

State/Province

Fukuoka

ZIP/Postal Code

813-0017

Country

Japan

Facility Name

Novartis Investigative Site

City

Iizuka-city

State/Province

Fukuoka

ZIP/Postal Code

820-8505

Country

Japan

Facility Name

Novartis Investigative Site

City

Kitakyushu-city

State/Province

Fukuoka

ZIP/Postal Code

807-8556

Country

Japan

Facility Name

Novartis Investigative Site

City

Takasaki-city

State/Province

Gunma

ZIP/Postal Code

370-0053

Country

Japan

Facility Name

Novartis Investigative Site

City

Hiroshima-city

State/Province

Hiroshima

ZIP/Postal Code

733-0032

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

060-0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

063-0811

Country

Japan

Facility Name

Novartis Investigative Site

City

Kamakura-city

State/Province

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawasaki-city

State/Province

Kanagawa

ZIP/Postal Code

210-0013

Country

Japan

Facility Name

Novartis Investigative Site

City

Sagamihara-city

State/Province

Kanagawa

ZIP/Postal Code

228-8522

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Novartis Investigative Site

City

Kumamoto-city

State/Province

Kumamoto

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

Novartis Investigative Site

City

Taihaku-ku

State/Province

Miyagi

ZIP/Postal Code

982-0032

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagano-city

State/Province

Nagano

ZIP/Postal Code

380-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagasaki-city

State/Province

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Sasebo-city

State/Province

Nagasaki

ZIP/Postal Code

857-1165

Country

Japan

Facility Name

Novartis Investigative Site

City

Kurashiki-city

State/Province

Okayama

ZIP/Postal Code

710-0016

Country

Japan

Facility Name

Novartis Investigative Site

City

Okayama-city

State/Province

Okayama

ZIP/Postal Code

700-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Tsukubo-gun

State/Province

Okayama

ZIP/Postal Code

701-0304

Country

Japan

Facility Name

Novartis Investigative Site

City

Hannan-city

State/Province

Osaka

ZIP/Postal Code

599-0212

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawachinagano-city

State/Province

Osaka

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawagoe

State/Province

Saitama

ZIP/Postal Code

350-1103

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokorozawa-city

State/Province

Saitama

ZIP/Postal Code

359-1111

Country

Japan

Facility Name

Novartis Investigative Site

City

Fuji-city

State/Province

Shizuoka

ZIP/Postal Code

417-0045

Country

Japan

Facility Name

Novartis Investigative Site

City

Hamamatsu-city

State/Province

Shizuoka

ZIP/Postal Code

430-8558

Country

Japan

Facility Name

Novartis Investigative Site

City

Fuchu

State/Province

Tokyo

ZIP/Postal Code

183-8524

Country

Japan

Facility Name

Novartis Investigative Site

City

Itabashi-ku

State/Province

Tokyo

ZIP/Postal Code

174-0071

Country

Japan

Facility Name

Novartis Investigative Site

City

Setagaya-ku

State/Province

Tokyo

ZIP/Postal Code

156-0052

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-0054

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Takaoka-city

State/Province

Toyama

ZIP/Postal Code

933-0874

Country

Japan

Facility Name

Novartis Investigative Site

City

Toyama-city

State/Province

Toyama

ZIP/Postal Code

930-0138

Country

Japan

Facility Name

Novartis Investigative Site

City

Shimonoseki-city

State/Province

Yamaguchi

ZIP/Postal Code

752-0976

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

Facility Name

Novartis Investigative Site

City

Mexicali

State/Province

Baja California

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexicali

State/Province

Baja California

ZIP/Postal Code

21200

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

11850

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Novartis Investigative Site

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Panama City

State/Province

Panamá

ZIP/Postal Code

0823-01510

Country

Panama

Facility Name

Novartis Investigative Site

City

Panama City

State/Province

Panamá

Country

Panama

Facility Name

Novartis Investigative Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Bangkok

State/Province

THA

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Khon Kaen

State/Province

THA

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novartis Investigative Site

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Leytonstone

State/Province

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cannock

State/Province

Staffordshire

ZIP/Postal Code

WS11 2XY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Salisbury

ZIP/Postal Code

SP2 8BJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31087226

Citation

Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.

Results Reference

derived

PubMed Identifier

29138986

Citation

Tahir H, Deodhar A, Genovese M, Takeuchi T, Aelion J, Van den Bosch F, Haemmerle S, Richards HB. Secukinumab in Active Rheumatoid Arthritis after Anti-TNFalpha Therapy: A Randomized, Double-Blind Placebo-Controlled Phase 3 Study. Rheumatol Ther. 2017 Dec;4(2):475-488. doi: 10.1007/s40744-017-0086-y. Epub 2017 Nov 14.

Results Reference

derived

Learn more about this trial

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents

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Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents (REASSURE)

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial