Study of efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritis

Phase 1

• Conditions: non-radiographic axial spondyloarthritis; MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-001106-33-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-09
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

• Male or non-pregnant, non-nursing female patients at least 18 years of age
• Diagnosis of axSpA according to ASAS axSpA criteria
• Objective signs of inflammation (MRI or abnormal CRP)
• Active axSpA as assessed by total BASDAI >=4 cm
• Spinal pain as measured by BASDAI question #2 = 4 cm (0-10 cm) at baseline
• Total back pain as measured by VAS = 40 mm (0-100 mm) at baseline
• Patients should have been on at least 2 different NSAIDs with an inadequate response
• Patients who have been on a TNFa inhibitor (not more than one) must have experienced an inadequate response
For the extension phase of the study:
• Patients who have completed the full study treatment period (104
weeks) in the core phase on study treatment.
• 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 505
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Patients with radiographic evidence for sacroiliitis, grade = 2 bilaterally or grade = 3 unilaterally
• Inability or unwillingness to undergo MRI
• Chest X-ray or MRI with evidence of ongoing infectious or malignant process
• Patients taking high potency opioid analgesics
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
• Pregnant or nursing (lactating) women
• Other protocol-defined exclusion criteria may apply

Study & Design

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