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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 12 October 2015
Main ID:  EUCTR2011-000102-21-IT
Date of registration: 09/01/2012
Prospective Registration: No
Primary sponsor: NOVARTIS FARMA
Public title: Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti- TNFa agents
Scientific title: A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents
Date of first enrolment: 28/06/2011
Target sample size: 548
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000102-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4  
Phase: 
Countries of recruitment
Brazil Bulgaria Canada Colombia Czech Republic Germany Hungary Italy
Mexico Russian Federation Slovakia Spain United States
Contacts
Name: Drug Regulatory Affairs   
Address:  Largo Umberto Boccioni, 1 21040 Origgio (VA) Italy
Telephone: +39 02 96541
Email: info.studiclinici@novartis.com
Affiliation:  Novartis Farma
Name: Drug Regulatory Affairs   
Address:  Largo Umberto Boccioni, 1 21040 Origgio (VA) Italy
Telephone: +39 02 96541
Email: info.studiclinici@novartis.com
Affiliation:  Novartis Farma
Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

Product Name: Secukinumab
Product Code: AIN457F
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Secukinumab
Current Sponsor code: AIN457
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: ORENCIA*IV 2FL 250MG+2SIR
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: Demonstrate the efficacy of secukinumab (75 or 150 mg) versus placebo (measured with ACR 20) after 24 weeks of treatment
Primary end point(s): ACR 20
Secondary Objective: - Change of the HAQ-DI from baseline on secukinumab 75 mg or 150 mg compared to placebo after 24 weeks of treatment - Proportion of patients achieving major clinical response on secukinumab 75 mg or 150 mg compared to placebo after 1 year of treatment - Proportion of patients achieving an ACR 20 response on secukinumab 75 mg or 150 mg compared to abatacept after 24 weeks of treatment - Change of the HAQ-DI from baseline on secukinumab 75 mg or 150 mg compared to abatacept after 24 weeks of treatment - Proportion of patients achieving major clinical response on secukinumab 75 mg or 150 mg compared to abatacept after 1 year of treatment
Timepoint(s) of evaluation of this end point: Week 24
Secondary Outcome(s)
Secondary end point(s): HAQ-DI, major clinical response
Timepoint(s) of evaluation of this end point: Week 24 and 1 year
Secondary ID(s)
2011-000102-21-CZ
CAIN457F2309
Source(s) of Monetary Support
Novartis Pharma
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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