Rheumatoid arthritis MedDRA version: 16.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Novartis Farma S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 74
Exclusion criteria
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 physiogically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment Other protocol-definied exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1- To evaluate the long-term safety and tolerability of secukinumab over time up to Week 260 in subjects with active rheumatoid arthritis 2- To assess long-term efficacy of secukinumab over time up to Week 260 with respect to: - The absolute values and change from baseline in DAS28 - The proportion of subjects achieving low disease activity (DAS28 = 3.2 and good/moderate EULAR response) - The proportion of subjects who achieve disease remission as defined by DAS28 (DAS28 < 2.6);Primary end point(s): ACR20, 50 and 70 (Response by American College of Rheumatology response criteria);Timepoint(s) of evaluation of this end point: Baseline, and every 3 months;Main Objective: To evaluate the long-term efficacy of secukinumab with respect to ACR20, ACR50 and ACR70 response over time up to Week 260 in subjects with active rheumatoid arthritis who had previously experienced an inadequate or intolerant response to anti-TNF-alpha therapy and who completed the CAIN457F2302 core study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Functional ability and activity restriction measure, HAQ-DI [1] - Proportion of patients achieving Major Clinical Response [1] - RA disease activity as measured by Disease Activity Score (DAS28) [1] - Proportion of subjects achieving Low Disease Activity and good/moderate EULAR responses [1] - Proportion of subjects achieving ACR/EULAR remission [1] - Changes in individual ACR components relative to baseline [1] - Changes in the van der Heijde total modified Sharp score relative to baseline [1] - Changes in the quality of life outcomes measured by SF-36 v2, relative to baseline [1] - Safety and tolerability [2] - Development of immunogenicity against secukinumab [3];Timepoint(s) of evaluation of this end point: [1] Baseline, and every 3 months [2] Baseline and every visit [3] Baseline, annually, and at study completion | — |
Countries
Argentina, Belgium, Canada, Colombia, Guatemala, Hungary, India, Italy, Japan, Mexico, Panama, Thailand, United States
Contacts
Public ContactDrug Regulatory Affairs
Novartis Farma S.p.A.
Outcome results
None listed