An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)

An Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability up to 4 Years in Patients With Juvenile Idiopathic Arthritis Subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis

ClinicalTrials.gov Identifier: NCT03769168

Novartis Reference Number: CAIN457F2304E1

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).

Condition 
Juvenile Psoriatic Arthritis
Enthesitis Related Arthritis
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
58 participants
Start date 
Jun 07, 2019
Completion date 
Nov 27, 2024
Gender 
All
Age(s)
2 Years and older (Child, Adult, Older Adult)

Interventions

Drug
AIN457
Secukinumab (AIN457) is a high-affinity fully human monoclonal anti- human antibody that target IL-17A and neutralizes activity.

Eligibility Criteria

Inclusion Criteria:

Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104.
Patients must be deemed by the investigator to benefit from continued secukinumab therapy.

Exclusion Criteria:

Plans for administration of live vaccines during the extension study period.
Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab.
Any patient who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms.

All other protocol related inclusion/exclusion criteria will apply.

Study Locations

United States
Novartis Investigative Site
Recruiting
Boise, 83702
Idaho
United States
Novartis Investigative Site
Active, not recruiting
Cincinnati, 45229
Ohio
United States
Novartis Investigative Site
Recruiting
Portland, 97232
Oregon
United States
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1200
-
Belgium
Novartis Investigative Site
Recruiting
Gent, 9000
-
Belgium
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22081
-
Germany
Novartis Investigative Site
Recruiting
Saint Augustin, 53757
-
Germany
Italy
Novartis Investigative Site
Recruiting
Genova, 16147
GE
Italy
Novartis Investigative Site
Recruiting
Napoli, 80131
-
Italy
Poland
Novartis Investigative Site
Recruiting
Krakow, 31503
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 119991
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Saint-Petersburg, 194100
-
Russian Federation
Novartis Investigative Site
Recruiting
Voronezh, 394036
-
Russian Federation
Novartis Investigative Site
Recruiting
Yekaterinburg, 620149
-
Russian Federation
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7925
-
South Africa
Spain
Novartis Investigative Site
Recruiting
Santiago de Compostela, 15706
Galicia
Spain
Novartis Investigative Site
Active, not recruiting
Valencia, 46026
-
Spain
Turkey
Novartis Investigative Site
Completed
Istanbul, 34303
Halkali
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34390
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]