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Therapeutic Areas: Rheumatology | Musculoskeletal | Immunology | Family Medicine
Disease Category: Rheumatoid Arthritis
Location: United States, GA

Clinical Trial Details

Overview

Research Study Summary

A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension

Purpose

This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done. The goals of these exploratory studies are to (1) find biomarkers that will identify persons with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to identify persons who will have fewer side effects in order to maximize their benefit from secukinumab.

Patient Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis
  • Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX, leflunamide or sulfasalazine)
  • Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or hydroxychloroquine) as long astheir dose was stable for 4 weeks prior to initiating study treatment
  • Disease activity at screening defined by =6 out of 28 tender joints and =6 out of 28 swollen joints and hsCRP >10mg/L

Patient Exclusion Criteria:

  • Patients with severe rheumatoid arthritis (functional status class IV according to the ACR 1991 revised criteria)
  • Previous exposure to secukinumab or any other biologic, including TNF inhibitors.
  • Use of high potency opioid analgesics
  • Pregnant or nursing (lactating) women
  • Use of any investigational drug other than RA therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomization, whichever is longer.
Other protocol-defined inclusion/exclusion criteria may apply

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Duration

12 Weeks

Facility Type

N/A

Contact

Denise Coats, Director of Clinical Research
Georgia Institute for Clinical Research, LLC
335 Roselane Street
Marietta, GA 30060
Phone: 770-420-4658

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Research Center Information: Georgia Institute for Clinical Research, LLC

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 182320

Date Last Changed: July 18, 2013


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