Rheumatoid Arthritis
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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-TNFalpha 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
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 Any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response [ Time Frame: 24 weeks ] A participant will be considered a responder according to ACR20 criteria if he/she has at least: 20 % improvement in tender 68-joint count, 20 % improvement in swollen 66-joint count and 20 % improvement in at least 3 of the following 5 measures:Patient's assessment of RA pain (VAS) - Patient's global assessment of disease activity (VAS) - Physician's global assessment of disease activity (VAS) - Subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score) - Acute phase reactant (C-reactive protein [hsCRP] or ESR) | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR50 response [ Time Frame: 24 weeks ] A participant will be considered a responder according to ACR50 criteria if he/she has at least: 50 % improvement in tender 68-joint count, 50 % improvement in swollen 66-joint count and 50 % improvement in at least 3 of the following 5 measures:Patient's assessment of RA pain (VAS) - Patient's global assessment of disease activity (VAS) - Physician's global assessment of disease activity (VAS) - Subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score) - Acute phase reactant (C-reactive protein [hsCRP] or ESR) Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Week 0 (BSL) and week 24 ] The HAQ-DI, assesses a subject's level of functional ability and includes 20 questions in 8 categories of functioning (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 to 3,representing normal, no difficulty(0),some difficulty(1), much difficulty(2), and unable to do(3). | — |
Outcome results
None listed