SpA: AIN 457F2320

Projekt

SpA: AIN 457F2320

Abgeschlossen · 2015 bis 2018

Müller Rüdiger, Forrer Silvia, Bartz-Batliner Mira, Hutz Carina Liane, Schmidig Kathrin

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Rheumatologie

Status

Abgeschlossen

Start

2015

Ende

2018

Finanzierungsart

Andere

Studiendesign

This is a randomized, double-blind, placebo-controlled, parallel-group study. Approximately 324 patients will be randomized to one of three treatment groups (secukinumab 150 mg Load, secukinumab 150 mg No Load, placebo, in a ratio of 1:1:1): • Group 1 (secukinumab 150 mg Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at BSL, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4 • Group 2 (secukinumab 150 mg No Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at BSL, followed by administration every four weeks starting at Week 4 • Group 3 (placebo): placebo (1 mL) s.c. PFS at BSL, Weeks 1, 2, 3, 4, 8, and 12, followed by secukinumab 150 mg (1 mL, 150 mg/mL) administration every four weeks starting at Week 16

Schlagwörter (Tags)

Spondyloarthritis, Antikörpertherapie

Kurzbeschreibung/Zielsetzung

A randomized, double-blind, placebo-controlled, phase III
multicenter study of subcutaneous secukinumab (150 mg)
with and without a subcutaneous loading regimen to
assess efficacy, safety, and tolerability up to 2 years in
patients with active ankylosing spondylitis