A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis

A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - CAIN457F2305

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36106

Enrollment

Registered

2011-07-29

Start date

2011-11-24

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankylosing spondylitis

Interventions

Treatment with Secukinumab or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Male or non-pregnant, non-lactating female patients at least 18 years of age • Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) • Patients should have been on NSAIDs with an inadequate response • Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose • Patients who have been on an anti-TNFa agent (not more than one) must have experienced an inadequate response Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion criteria: • Chest X-ray with evidence of ongoing infectious or malignant process • Patients with total ankylosis of the spine • Patients previously treated with any biological immunomodulating agents except for those targeting TNFa • Previous treatment with any cell-depleting therapies Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
ASAS20.	—

Secondary

Measure	Time frame
ASAS20, ASAS40, adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)