A randomized, partially-blinded, active-controlled multicenter 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
- Conditions
- ankylosing spondylitisBechterews syndrome10023213
- Registration Number
- NL-OMON55618
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
- 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/non biologic 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 >= 5mg/L OR presence of at least 1 syndesmophyte on centrally read
spinal X-ray.
- 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 TNFa.
- Subjects taking high potency opioid analgesics.
- Previous treatment with any cell-depleting therapies including but not
limited to anti-CD20, investigational agents.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective:<br /><br>To demonstrate the proportion of subjects on each secukinumab dose with no<br /><br>radiographic progression as measured by mSASSS at Week 104 is superior to<br /><br>subjects on GP2017 (adalimumab biosimilar).</p><br>
- Secondary Outcome Measures
Name Time Method