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

• Conditions: Rheumatoid arthritis; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-000275-13-GB
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-18
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

• Male or non-pregnant, non-lactating female patients at least 18 years of age
• 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

• 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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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<br>• Change of the van der Heijde total modified Sharp score from baseline on secukinumab compared to placebo<br>• Proportion of patients achieving major clinical response on secukinumab 75 mg or 150 mg compared to placebo after 1 year of treatment<br>;Primary end point(s): ACR 20;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
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