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Long-Term Safety of Secukinumab for Autoimmune Inflammation

Phase 4

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is for people who have completed a Novartis trial for secukinumab, and the study is to assess the long term safety for these participants.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial continues treatment with Secukinumab injections for patients previously on it, aiming to assess long-term safety. Participants must have completed an earlier Novartis trial and be unable to obtain the drug otherwise.See study design

What are the potential side effects?

While specific side effects aren't listed here, as this is an extension of prior trials, typical reactions may include injection site reactions, increased infection risk, and potential autoimmune responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate long term safety as assessed by occurrence of AEs/SAEs

Trial Design

1Treatment groups

Experimental Treatment

Group I: Secukinumab s.c.Experimental Treatment1 Intervention

Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,856 Previous Clinical Trials

4,196,990 Total Patients Enrolled

Media Library

Secukinumab s.c. injection Clinical Trial Eligibility Overview. Trial Name: NCT04638647 — Phase 4

Autoimmune Inflammation Research Study Groups: Secukinumab s.c.

Autoimmune Inflammation Clinical Trial 2023: Secukinumab s.c. injection Highlights & Side Effects. Trial Name: NCT04638647 — Phase 4

Secukinumab s.c. injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04638647 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Secukinumab s.c. injection typically utilized in patient care?

"Secukinumab s.c. injection is a common therapeutic option for ankylosing spondylitis and can also be utilized to treat enthesitis related arthritis (ERA), severe plaque psoriasis, and psoriatic arthritis."

Answered by AI

Are recruitment efforts still underway for this clinical experiment?

"Affirmative. Clinicaltrials.gov hosts information which reveals that the trial, initially posted on December 22nd 2020 is in search of new participants. All told, 715 people need to be recruited from 14 distinct sites."

Answered by AI

Has Secukinumab s.c. injection been studied in other research trials?

"Presently, there are 27 trials for Secukinumab s.c. injection in action; 13 of these investigations fall into Phase 3 testing. Despite the majority of experiments occurring in Brest and Buenos Aires, numerous test centres across 1040 locations offer this therapy to patients."

Answered by AI

How many sites are currently facilitating this clinical experiment?

"Currently, 14 distinct sites across the United States are hosting this trial. Locations include Cumberland, Van Nuys and Denver as well as other nearby centres; it is wise to choose a site that best fits one's geographical needs in order to limit travel time."

Answered by AI

How many individuals have enrolled in this trial to date?

"Affirmative. According to clinicaltrials.gov, this medical trial is presently enrolling patients and was first published on December 22nd 2020. The study seeks 715 individuals from 14 different sites with the most recent update being July 14th 2022."

Answered by AI

Has Secukinumab s.c. injection been granted the green light from the FDA?

"The safety of Secukinumab s.c. injection has been verified through Phase 4 clinical trials and is given a score of 3 by the Power team's assessment scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Secukinumab Open Label Roll-over Extension Protocol

2020. "Secukinumab Open Label Roll-over Extension Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04638647.

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