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

NCT01770379 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2016-07-21

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Secukinumab (AIN457)

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17)

BIOLOGICAL

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • Argentina
  • Brazil
  • Colombia
  • Czechia
  • Dominican Republic
  • Germany
  • Greece
  • Guatemala
  • India
  • Italy
  • Japan
  • Panama
  • Portugal
  • South Africa
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01770379 on ClinicalTrials.gov