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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05677542
• Collaborator: (none)
• Enrollment: 758
• Locations: 3
• Actual Duration (Months): 7
• Patients Per Site: 252.7
• Patients Per Site Per Month: 36.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Axial Spondyloarthritis; Psoriatic Arthritis	Drug: secukinumab

Study Design

• Study Type: Observational
• Actual Enrollment: 758 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study
• Actual Study Start Date: Jun 2, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Madrid		Spain
2	Novartis Investigative Site	Malaga		Spain
3	Novartis Investigative Site	Valencia		Spain

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05677542
• Other Study ID Numbers: CAIN457FES07
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 10, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Novartis Pharmaceuticals: Axial spondyloarthritis;; Psoriatic Arthritis;; electronic health records;; natural language processing;; artificial intelligence
• Additional relevant MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis

Study Results

No Results Posted as of Jan 10, 2023