Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to demonstrate the impact of secukinumab on progression of structural damage in the spine, as measured by the mSASSS in patients with AS.

Official Title

A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis ankylosing spondylitis, AS, secukinumab, GP2017, adalimumab biosimilar, mSASSS, ASAS20 Spondylitis Spondylitis, Ankylosing Adalimumab Antibodies, Monoclonal Secukinumab GP2017 (adalimumab biosimilar) Secukinumab 150 mg s.c. Secukinumab 300 mg s.c. GP2017 (adalimumab biosimilar) 40mg s.c.

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or non-pregnant, non-nursing female patients at least 18 years of age
  • Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence(centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy
  • Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10
  • Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)
  • Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)
  • hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

You CAN'T join if...

  • Patients with total ankylosis of the spine
  • Pregnant or nursing (lactating) women
  • Evidence of ongoing infectious or malignant process
  • Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα
  • Subjects taking high potency opioid analgesics
  • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents

Other protocol-defined inclusion/exclusion criteria may apply

Locations

  • Novartis Investigative Site accepting new patients
    San Francisco California 94143 0138 United States
  • Novartis Investigative Site accepting new patients
    La Mesa California 91942 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03259074
Phase
Phase 3
Study Type
Interventional
Last Updated