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A Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy in the Treatment of Enthesitis at the Achilles Tendon up to 1 Year in Adult Patients With Active Psoriatic Arthritis (PsA) and Axial Spondyloarthritis (axSpA) (ACHILLES)
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.
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)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Plovdiv, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Stara Zagora, Bulgaria
Novartis Investigative Site
Targovishte, Bulgaria
Novartis Investigative Site
Prague, Czech Republic, Czechia
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Uherské Hradiště, Czechia
Novartis Investigative Site
Berlin, Germany
Start Date
August 30, 2016
Primary Completion Date
December 11, 2019
Completion Date
December 11, 2019
Last Updated
May 3, 2021
204
ACTUAL participants
Secukinumab
BIOLOGICAL
Secukinumab Placebo
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT07295509
NCT06100744
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04402086