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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02008916
Other study ID # CAIN457F2314
Secondary ID 2013-001090-24
Status Completed
Phase Phase 3
First received
Last updated
Start date January 14, 2014
Est. completion date December 11, 2017

Study information

Verified date December 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.


Recruitment information / eligibility

Status Completed
Enrollment 226
Est. completion date December 11, 2017
Est. primary completion date February 23, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Secukinumab
AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).
Placebo secukinumab
Placebo to AIN457 (Secukinumab)

Locations

Country Name City State
Belgium Novartis Investigative Site Aalst
Belgium Novartis Investigative Site Bruxelles
Czechia Novartis Investigative Site Praha 2
Czechia Novartis Investigative Site Uherske Hradiste Czech Republic
Germany Novartis Investigative Site Bad Doberan
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Cottbus
Germany Novartis Investigative Site Erlangen
Germany Novartis Investigative Site Erlangen
Germany Novartis Investigative Site Gottingen
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Herne
Germany Novartis Investigative Site Jena
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Zerbst
Greece Novartis Investigative Site Athens GR
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Heraklion
Greece Novartis Investigative Site Thessaloniki GR
Mexico Novartis Investigative Site Culiacan MEX
Mexico Novartis Investigative Site Mexicali Baja California
Mexico Novartis Investigative Site Torreon Coahuila
Portugal Novartis Investigative Site Almada
Portugal Novartis Investigative Site Lisboa
Portugal Novartis Investigative Site Lisboa
Portugal Novartis Investigative Site Lisboa
Russian Federation Novartis Investigative Site Kazan
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site St Petersburg
Russian Federation Novartis Investigative Site St-Petersburg
Spain Novartis Investigative Site Cordoba Andalucia
Spain Novartis Investigative Site El Palmar Murcia
Spain Novartis Investigative Site La Coruna Galicia
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Sabadell Barcelona
Spain Novartis Investigative Site Santander Cantabria
United Kingdom Novartis Investigative Site London England
United Kingdom Novartis Investigative Site Norwich
United Kingdom Novartis Investigative Site Torquay
United States Novartis Investigative Site Albany New York
United States Novartis Investigative Site Austin Texas
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Duncansville Pennsylvania
United States Novartis Investigative Site Jackson Tennessee
United States Novartis Investigative Site Mesa Arizona
United States Novartis Investigative Site Mesquite Texas
United States Novartis Investigative Site Mobile Alabama
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Palm Harbor Florida
United States Novartis Investigative Site Passaic New Jersey
United States Novartis Investigative Site Pembroke Pines Florida
United States Novartis Investigative Site Peoria Arizona
United States Novartis Investigative Site Upland California

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Germany,  Greece,  Mexico,  Portugal,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo. 16 weeks
Secondary ASAS 40 Response ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo. 16 weeks
Secondary Serum hsCRP Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time. Baseline and 16 weeks
Secondary ASAS 5/6 Response ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo. 16 weeks
Secondary Bath Ankylosing Spondylitis Disease Activity Index / BASDAI BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo. Baseline and 16 weeks
Secondary Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe) Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits. Week 8 and Week 12
Secondary Pre-filled Syringe Possible Hazard The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits. Week 8 and Week 12
Secondary Prefilled Syringe Patient Satisfaction Assessment The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection. Baseline, weeks 8, 12 and 16
Secondary ASAS Partial Remission ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo. 16 weeks
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