A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3.5 Years in Subjects With Active Psoriatic Arthritis

Last updated: February 25, 2016
Sponsor: Novartis
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

TX139140
  • All Genders

Study Summary

A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3.5 Years in Subjects With Active Psoriatic Arthritis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.

  • Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

  • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

  • Inadequate control of symptoms with NSAID.

Exclusion

Exclusion Criteria:**

  • Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
  • Subjects taking high potency opioid analgesics.
  • Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
  • Ongoing use of prohibited psoriasis treatments / medications.
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa.
  • Previous treatment with any cell-depleting therapies.

Study Design

Study Start date:
September 03, 2014
Estimated Completion Date:

Study Description

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, as well as up to 3.5-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFa) therapy.

Novartis Pharmaceuticals 1-888-669-6682
ClinicalTrials.gov identifier: NCT01989468

Connect with a study center

  • Centro de Investigacion Clinica

    Caguas, XX 725
    Puerto Rico

    Active - Recruiting

  • Ponce School Of Medicine

    Ponce, XX 717
    Puerto Rico

    Active - Recruiting

  • Arthritis and Rheumatic Disease Specialities

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Center for Arthritis and Rheumatic Diseases

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Arthritis Center

    Palm Harbor, Florida 34684
    United States

    Active - Recruiting

  • Sarasota Arthritis Research Center

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Florida Medical Clinic PA

    Zephyrhills, Florida 33542
    United States

    Active - Recruiting

  • Deerbrook Medical Associates

    Vernon Hills, Illinois 60061
    United States

    Active - Recruiting

  • Dawes-Fretzin Clinical Research

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Graves Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Active - Recruiting

  • Clayton Medical Research

    St. Louis, Missouri 63117
    United States

    Active - Recruiting

  • Arthritis and Osteoporosis Associates

    Freehold, New Jersey 07728
    United States

    Active - Recruiting

  • The Center for Rheumatology

    Albany, New York 12206
    United States

    Active - Recruiting

  • Austin Regional Clinic Rheumatology

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Southwest Rheumatology

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • The Vancouver Clinic Research Center

    Vancouver, Washington 98664
    United States

    Active - Recruiting

  • Wenatchee Medical Center

    Wenatchee, Washington 98801
    United States

    Active - Recruiting

  • Ponce School Of Medicine

    Ponce, XX 717
    United States

    Active - Recruiting

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