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Monoclonal Antibodies

Secukinumab for Juvenile Arthritis

Phase 3
Waitlist Available
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 308 weeks
Awards & highlights

Study Summary

This trial is investigating whether secukinumab is effective and safe in treating two subtypes of Juvenile Idiopathic Arthritis: Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis.

Who is the study for?
This trial is for young patients with Juvenile Psoriatic Arthritis (JPsA) or Enthesitis Related Arthritis (ERA) who completed a previous secukinumab study. They should be seeing benefits from the treatment to qualify, and can't be on other biologic immunomodulators or planning to receive live vaccines.Check my eligibility
What is being tested?
The trial is an extension study testing the long-term effects and safety of secukinumab, known as AIN457, in children with JPsA and ERA. It's open label, meaning everyone knows they're getting the actual drug, not a placebo.See study design
What are the potential side effects?
Secukinumab may cause side effects like infections due to immune system suppression, allergic reactions at injection sites, diarrhea, upper respiratory tract infections, and possibly others that are less common.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~308 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 308 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with JIA ACR30 response
Secondary outcome measures
Number of participants with JIA ACR 50/70/90/100 response
Number of participants with Juvenile Arthritis Disease Activity Score (JADAS)
Number of participants with inactive disease status
+3 more

Side effects data

From 2019 Phase 3 trial • 383 Patients • NCT03136861
4%
Headache
3%
Oropharyngeal pain
2%
Diarrhoea
2%
Fatigue
2%
Pain in extremity
2%
Nasopharyngitis
1%
Hypertension
1%
Pruritus
1%
Cough
1%
Proteinuria
1%
Pharyngitis
1%
Upper respiratory tract infection
1%
Blood creatinine increased
1%
Arthralgia
1%
Abdominal pain
1%
Injection site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 150 mg (Group A)
Placebo (Group B)
Arm A2
Arm A3
Arm B1
Arm B2
Arm A1

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2 - Secukinumab 150 mgExperimental Treatment1 Intervention
Group 2 - Secukinumab (AIN457) 150 mg/1.0mL
Group II: Group 1 - Secukinumab 75 mgExperimental Treatment1 Intervention
Group 1 - Secukinumab (AIN457) 75 mg/0.5mL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AIN457
2017
Completed Phase 3
~2550

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,863 Previous Clinical Trials
4,199,280 Total Patients Enrolled
20 Trials studying Psoriatic Arthritis
11,060 Patients Enrolled for Psoriatic Arthritis

Media Library

AIN457 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03769168 — Phase 3
Psoriatic Arthritis Research Study Groups: Group 2 - Secukinumab 150 mg, Group 1 - Secukinumab 75 mg
Psoriatic Arthritis Clinical Trial 2023: AIN457 Highlights & Side Effects. Trial Name: NCT03769168 — Phase 3
AIN457 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03769168 — Phase 3

Frequently Asked Questions

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

Are people currently being recruited for this clinical trial?

"This research is no longer looking for volunteers. The trial was initially advertised on 6/7/2019 and the most recent update was 8/2/2022. However, there are presently 395 studies actively admitting patients with juvenile psoriatic arthritis and 28 trials for AIN457 that need participants."

Answered by AI

What is the common purpose that AIN457 serves?

"AIN457 is commonly used to treat ankylosing spondylitis. AIN457 can also be effective at treating other conditions like psoriatic arthritis, enthesitis related arthritis (era), and severe plaque psoriasis."

Answered by AI

How many patients are being accepted into the trial?

"Currently, this clinical trial is not looking for new patients. However, there are 395 other studies seeking juvenile psoriatic arthritis patients and 28 trials searching for AIN457 participants that are currently admitting patients."

Answered by AI

Are there other examples of research that has been done with AIN457?

"There are a total of 28 clinical trials underway that are studying AIN457. Of these, 13 have progressed to Phase 3 testing. The primary locations for these studies are Brest and Buenos Aires; however, there are 1040 different sites running investigations for this potential treatment."

Answered by AI

What are some of the dangers associated with AIN457?

"AIN457 safety is estimated to be a 3. This is based on the fact that it is a Phase 3 trial, meaning preliminary data suggests efficacy and there are multiple rounds of data supporting safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
2019. "An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03769168.
All > Arthritis > Psoriatic Arthritis
~3 spots leftby Oct 2024
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