Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti- TNFa agents

• 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

Countries of recruitment

Brazil, Bulgaria, Canada, Colombia, Czech Republic, Germany, Hungary, Italy, Mexico, Russian Federation, Slovakia, Spain, United States

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma

• Name: Drug Regulatory Affairs
• 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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rheumatoid arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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

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

Primary end point(s): ACR 20

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