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NCT05368818 · ClinicalTrials.gov registry record
An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 767
- Enrollment target
NCT05368818: Completed study, sponsored by Novartis Pharmaceuticals.
NCT05368818 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 767 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05368818 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 767 participants
- Enrollment target
Study Summary
This was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudinal data within the registry to track the trends relating to the disease. For the analysis of improvement and patient reported QoL, patients with a minimum of one follow-up visit were included. The index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \& 24-months post-index.
Primary Outcome
Patient reported QoL for five specific DLQI domains from baseline up to 24 months of UK/ROI psoriasis patients enrolled in BADBIR who were initiated on secukinumab treatment were reported. Following 5 domains were included: * Embarrassment and/or self conciousness * Social leisure * Work/study * Problems relating to partner, friends and relatives * Sexual difficulties
Interventions
- OTHER Secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 767 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2021-05-06 |
What the finished NCT05368818 record still lists
NCT05368818 is an observational study that tracks outcomes without assigning an intervention. The registered 767 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Secukinumab is the first listed.
NCT05368818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05368818 about?
NCT05368818 is a clinical study titled "An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source". This was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudi...
What is the current status of trial NCT05368818?
This trial is currently completed. The enrollment target is 767 participants. The study started on 2020-12-07. Estimated completion is 2021-05-06.
What interventions are being tested in trial NCT05368818?
The interventions under investigation include: Secukinumab (OTHER).
Who is sponsoring clinical trial NCT05368818?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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