Long-Term Safety of Secukinumab for Autoimmune Inflammation
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial focuses on participants who are already benefiting from secukinumab, it seems likely that you would continue with this medication.
What data supports the effectiveness of the drug Secukinumab?
Secukinumab has been shown to be effective in treating conditions like psoriatic arthritis and ankylosing spondylitis, improving symptoms and quality of life for patients. Clinical trials have demonstrated its ability to reduce disease signs and symptoms, and it is generally well tolerated with mild to moderate side effects.12345
How is the drug secukinumab different from other treatments for autoimmune inflammation?
Secukinumab is unique because it is the first drug in its class to target interleukin-17A, a protein involved in inflammation, making it different from other treatments that target different pathways. It is administered as an injection under the skin and has shown effectiveness in conditions like psoriasis, psoriatic arthritis, and ankylosing spondylitis, especially for patients who do not respond well to other treatments.12456
Eligibility Criteria
This trial is for people who have benefited from Secukinumab in a previous Novartis study, can't get it commercially due to local guidelines, and are judged by the researcher to still benefit from it. It's not for those who stopped early in the earlier study or women able to have children not using contraception.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive secukinumab treatment based on their previous trial dosage, with potential dose adjustments based on clinical need
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive secukinumab treatment to assess long-term safety
Treatment Details
Interventions
- Secukinumab (Monoclonal Antibodies)