Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Active, not recruiting

• Conditions: Rheumatoid arthritis; MedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-006058-94-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-19
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

1) Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months

2) 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

3) Intake of at least one anti-TNF-a 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

Other protocol-defined inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 187
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47

Exclusion Criteria

1) Current RA functional status class IV according to the ACR 1991 revised criteria

2) Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes

3) Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Measure the proportion of subjects achieving an ACR20 response compared to placebo at week 24.;Secondary Objective: 1) Demonstrate that the efficacy of secukinumab 75mg or 150mg at Week 24 is superior to placebo in patients with active RA with respect to change from baseline in DAS28-CRP.<br><br>2) Measure the disability assessment component of the HAQ (Health Assessment Questionnaire – Disability Index) at week 24 compared to baseline.<br><br>3) Measure the proportion of subjects achieving an ACR50 response compared to placebo at week 24.;Primary end point(s): ACR20;Timepoint(s) of evaluation of this end point: week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Disease Activity Score utilizing CRP (DAS28-CRP).<br>2) Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)<br>3) ACR50;Timepoint(s) of evaluation of this end point: week 24<br>