Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

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-TNFa agents - REASSURE 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006058-94-CZ

Enrollment

234

Registered

2012-07-19

Start date

2012-09-26

Completion date

Unknown

Last updated

2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB CAS Number: 1229022-83-6 Current Sponsor code: AIN457

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months 2) 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 3) 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 Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 187 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 47

Exclusion criteria

Exclusion criteria: 1) Current RA functional status class IV according to the ACR 1991 revised criteria 2) 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 3) Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: Measure the proportion of subjects achieving an ACR20 response compared to placebo at week 24.;Secondary Objective: 1) Demonstrate that the efficacy of secukinumab 75mg or 150mg at Week 24 is superior to placebo in patients with active RA with respect to change from baseline in DAS28-CRP. 2) Measure the disability assessment component of the HAQ (Health Assessment Questionnaire – Disability Index) at week 24 compared to baseline. 3) Measure the proportion of subjects achieving an ACR50 response compared to placebo at week 24.;Primary end point(s): ACR20;Timepoint(s) of evaluation of this end point: week 24	—

Measure

Time frame

Main Objective: Measure the proportion of subjects achieving an ACR20 response compared to placebo at week 24.;Secondary Objective: 1) Demonstrate that the efficacy of secukinumab 75mg or 150mg at Week 24 is superior to placebo in patients with active RA with respect to change from baseline in DAS28-CRP. 2) Measure the disability assessment component of the HAQ (Health Assessment Questionnaire – Disability Index) at week 24 compared to baseline. 3) Measure the proportion of subjects achieving an ACR50 response compared to placebo at week 24.;Primary end point(s): ACR20;Timepoint(s) of evaluation of this end point: week 24

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Disease Activity Score utilizing CRP (DAS28-CRP). 2) Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) 3) ACR50;Timepoint(s) of evaluation of this end point: week 24	—

Countries

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

Contacts

Public ContactInformacní služba - klin. hodnocení

Novartis s.r.o.

dotazy.klinickehodnoceni@novartis.com+420225 775 207

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026