Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)

Phase 1

• Conditions: Ankylosing spondylitis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; MedDRA version: 15.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2012-000046-35-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-26
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
2. Male or non-pregnant, non-lactating female patients at least 18 years of age.
3. Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist?s report) fulfilling the Modified New York criteria for AS (Appendix 3) with active AS assessed by BASDAI ?4 (0-10) and spinal pain as measured by VAS?4 cm at Baseline.
4. Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to randomization with an inadequate response or failure to respond, or less
than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
5. Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation.

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 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1. Chest x-ray or MRI with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician.
2. Patients with total ankylosis of the spine.
3. Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)
4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor.

Other protocol-defined exclusion criteria may apply.

Study & Design

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