3-year follow-up study of secukinumab treatment in patients with active Ankylosing Spondylitis

Phase 1

• Conditions: Ankylosing spondylitis; MedDRA version: 16.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-001089-40-IT
• Lead Sponsor: ovartis Farma SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-02
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Patients having completed the core study CAIN457F2305.
- Indication for treatment extension

Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 285
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- History of hypersensitivity to secukinumab or to any drug of similar chemical classes.
- Use of any investigational drug other than secukinumab during the core study CAIN457F2305.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the sustainability of subject benefits as quantified by ASAS20 (Assessment of SpondyloArthritis International Society criteria) in the whole study population during long-term (Week 260) treatment with secukinumab 75 and 150 mg provided as prefilled syringes.;Secondary Objective: 1. To evaluate the sustainability of subject benefits in subjects with active AS as quantified by the ASAS40 response during long-term treatment with secukinumab 75 or 150 mg.<br><br>2. To evaluate the overall safety and tolerability of secukinumab in subjects with active AS over time up to Week 260.;Primary end point(s): Assessment of Spondyloarthritis International Society criteria / ASAS 20 response;Timepoint(s) of evaluation of this end point: 260 weeks (including the 2-year duration of the core study CAIN457F2305)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - ASAS 40<br>- Overall safety and tolerability;Timepoint(s) of evaluation of this end point: 260 weeks (including the 2-year duration of the core study CAIN457F2305)