Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • UT Southwestern-Other
  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System


Principal Investigator

Official Title

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents

Brief Overview

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS)
for subcutaneous self-administration in patients with active rheumatoid arthritis who are
intolerant to or have had an inadequate response to anti-TNF-α agents.

Participant Eligibility

Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised
criteria for at least 3 months •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 •Intake of
at least one anti-TNF-α 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
Exclusion Criteria:

- Current RA functional status class IV according to the ACR 1991 revised criteria
•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. Other protocol-defined inclusion/exclusion
criteria may apply