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

December 22, 2022 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

758

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Novartis Investigative Site
      • Malaga, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Axial Spondyloarthritis Patients
Patients with Axial Spondyloarthritis
Drug: secukinumab
all patients who received secukinumab
Psoriatic Arthritis Patients
Patients with Psoriatic Arthritis
Drug: secukinumab
all patients who received secukinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment
Time Frame: month 6

Disease control was defined as:

For Axial Spondyloarthritis (axSpA) population: Bath Ankylosing Spondylitis Functional Index (BASDAI) score < 4. If BASDAI was not available, Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 was used.

For Psoriatic Arthritis (PsA) population: Disease Activity in PSoriatic Arthritis (DAPSA) score < 14. If DAPSA was not available, Disease activity score 28 (DAS-28) < 3.2 was used.
month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457FES07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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