Psoriatic Arthritis Clinical Trial
Official title:
Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study
| NCT number | NCT05677542 |
| Other study ID # | CAIN457FES07 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2, 2021 |
| Est. completion date | December 31, 2021 |
| Verified date | December 2022 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 758 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | |
| Spain | Novartis Investigative Site | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients achieving disease control status at 6 months (±3 months) of secukinumab treatment | 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 |
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