SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis

Launched by NOVARTIS PHARMACEUTICALS · Apr 28, 2017

Keywords

ClinConnect Summary

The study consisted of 2 treatment periods: a double-blind, placebo-controlled period from Baseline to Week 8 (Treatment Period 1) and a double-blind secukinumab treatment period from Week 8 to Week 24 (Treatment Period 2).

At Baseline (Treatment Period 1), patients were randomized in a 3:1 ratio to either secukinumab 150 mg (Group A) or placebo (Group B). At Week 8 (Treatment Period 2), patients were re-randomized and re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg.

Patients assigned to secukinumab 150 mg (Group A) at Baseline ...

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Diagnosis of axial spondylarthritis (axSpA, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to ASAS axSpA classification criteria
• • patients with back pain for at least 3 months and age of onset less than 45 years
• • Active axSpA as assessed by total BASDAI score of at least 4 at Baseline.
• • Spinal pain numeric rating scale score of more than 4 at Baseline.
• • inadequate response to or failure to respond to at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization
• Key Exclusion Criteria:
• • Chest X-ray or MRI with evidence of ongoing infectious or malignant process
• • Patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha.
• • Patients who have been exposed to more than one anti-tumor necrosis factor alpha agent.
• • Active ongoing inflammatory diseases other than axial spondyloarthritis
• • Other ongoing mechanical diseases affecting the spine.