Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

NCT ID: NCT05677542

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

758 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-02

Study Completion Date

2021-12-31

Brief Summary

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This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.

Detailed Description

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Conditions

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Axial Spondyloarthritis Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Axial Spondyloarthritis Patients

Patients with Axial Spondyloarthritis

secukinumab

Intervention Type DRUG

all patients who received secukinumab

Psoriatic Arthritis Patients

Patients with Psoriatic Arthritis

secukinumab

Intervention Type DRUG

all patients who received secukinumab

Interventions

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secukinumab

all patients who received secukinumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged ≥ 18 years.
* Diagnosed with axSpA or PsA.
* Had received or are receiving bDMARD, independently of the line of treatment, from January 2018 to data collection.
* Had at least 3 months follow up from first bDMARD administration.
* Patients with EHRs.

Exclusion Criteria

• Receiving bDMARD within a clinical trial from January 2018 to data collection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Málaga, , Spain

Site Status

Novartis Investigative Site

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CAIN457FES07

Identifier Type: -

Identifier Source: org_study_id

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