NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Rheumatoid Arthritis
Date of first enrollment	18/03/2013
Target sample size	234
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : AIN457 INN of investigational material : secukinumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : subcutaneously 75mg, 150mg

Outcome(s)

Primary Outcome

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 Outcome

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).

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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