Rheumatoid arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Novartis Pharma Services 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 = 10mg/L ESR = 28 mm/1st hr - Patients must have been taking at least one anti-TNFa agents 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-TNFa agent - Patients must be taking Methotrexate or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7,5 to 25mg/week for Methotrexate or other DMARD at maximum tolerated dose) 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 439 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 109
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 (75 or 150 mg) versus placebo (measured with ACR 20) after 24 weeks of treatment;Secondary Objective: Key secondary objectives: - Secukinumab 75mg or 150mg is superior to placebo with respect to change from baseline in DAS28 -CRP at Week 24. - Change of the HAQ-DI from baseline on secukinumab 75 mg or 150 mg compared to placebo after 24 weeks - Secukinumab 75mg or 150mg is superior to placebo with regards to the proportion of patients achieving ACR50 at Week 24 ;Primary end point(s): ACR 20;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): First key (ranked) secondary objective: DAS28-CRP Second key (ranked) secondary objective: HAQ-DI Final key (ranked) secondary objective: ACR50 responder rate ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Germany, Hungary, Italy, Mexico, Romania, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactInformacní služba - klin. hodnocení
Novartis s.r.o.
Outcome results
None listed