Clinical Trial: Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes, to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tol

Brief Summary: To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with ankylosing spondylitis at Week 16 and long term efficacy and safety up to Week 52.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: The proportion of participants who achieve an ASAS 20 response (Assessment of SpondyloArthritis International Society criteria) [ Time Frame: Week 16 ]

ASAS20 response is defined as an improvement of ≥20% and ≥1 units on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The proportion of participants who achieve an ASAS 40 reponse [ Time Frame: Week 16 ]
    ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
  • Change in hsCRP over time [ Time Frame: Week 16 ]
    hsCRP is measured as a marker of inflammation from blood samples during the study
  • The proportion of participants who achieve an ASAS 5/6 [ Time Frame: Week 16 ]
    The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains
  • Change in BASDAI over time [ Time Frame: Week 16 ]
    The BASDAI consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS
  • Change in SF-36 PCS over time [ Time Frame: Week 16 ]
    The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions
  • Change in ASQoL score over time [ Time Frame: Week 16 ]
    The ASQoL is an instrument to assess health-related quality of life among adult patients with Ankylosing Spondylitis
  • The proportion of patients who achieve an ASAS partial remission [ Time Frame: Week 16 ]
    The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: May 4, 2016
Date Started: October 2016
Date Completion: March 2019
Last Updated: December 9, 2016
Last Verified: December 2016