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Clinical Trial Summary

The purpose of this study was to demonstrate efficacy, including effects on inflammation by magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis for up to 1 year with a primary focus at Week 24, in patients with active Psoriatic Arthritis and axial Spondyloarthritis despite current or previous non-steroidal anti-inflammatory drugs (NSAID) and/or disease modifying anti-rheumatic drug (DMARD) and/or anti-TNFα therapy.


Clinical Trial Description

Primary endpoint was at week 24 but there was no interim Clinical Study Report. While Protocol states at chapter 9.7 that a week 24 analysis may be provided (not mandatory as per protocol), all data has been analyzed at week 52. Some of the secondary endpoints include the whole study period up to week 52 (to address questions on switching placebo to active drug) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02771210
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date August 30, 2016
Completion date December 11, 2019

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