Rheumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or non-pregnant, non-lactating female patients • Presence of Rheumatoid Arthritis classified by 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-CCP antibodies positive OR Rheumatoid Factor positive AND WITH at least 1 of the following at screening: hsCRP = 10 mg/L OR ESR = 28 mm/1st hr • Patients must have been taking at least one anti-TNF-a 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-a 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)) Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 504 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
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 • Rheumatoid arthritis patients functional status class IV according to the ACR 1991 revised criteria • Patients who have ever received biologic immunomodulating agents except for those targeting TNFa • Previous treatment with any cell-depleting therapies Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the efficacy of secukinumab (75mg or 150mg) versus placebo (measured with ACR 20) after 24 weeks of treatment;Secondary Objective: • Change of the HAQ-DI from baseline on secukinumab 75 mg or 150 mg compared to placebo after 24 weeks of treatment • Change of the van der Heijde total modified Sharp score from baseline on secukinumab compared to placebo • Proportion of patients achieving major clinical response on secukinumab 75 mg or 150 mg compared to placebo after 1 year of treatment ;Primary end point(s): ACR 20;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HAQ-DI,van der Heijde total modified Sharp score and Major clinical response;Timepoint(s) of evaluation of this end point: Week 24 and 1 year | — |
Countries
Argentina, Belgium, Canada, Colombia, Guatemala, Hungary, India, Italy, Japan, Mexico, Panama, Peru, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactPublic Information Desk
Novartis Hungary Ltd. Pharma
Outcome results
None listed