Secukinumab s.c. injection for Autoimmune Inflammation

Novartis Investigative Site, West Hills, CA
Autoimmune InflammationSecukinumab s.c. injection - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Autoimmune Inflammation

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: up to 2 years

up to 2 years
To evaluate long term safety as assessed by occurrence of AEs/SAEs

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Secukinumab s.c.
1 of 1

Experimental Treatment

715 Total Participants · 1 Treatment Group

Primary Treatment: Secukinumab s.c. injection · No Placebo Group · Phase 4

Secukinumab s.c.
Biological
Experimental Group · 1 Intervention: Secukinumab s.c. injection · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,771 Previous Clinical Trials
3,829,519 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently using secukinumab and the doctor thinks it's still benefiting you more than the potential risks.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.