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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104. 2. Patients must be deemed by the investigator to benefit from continued secukinumab therapy.

Exclusion Criteria:

1. Plans for administration of live vaccines during the extension study period. 2. Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab. 3. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03769168
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Germany, Italy, Poland, Russian Federation, Spain, Turkey, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
Additional Details

NOTE: Detailed Description : data not entered

Arms & Interventions

Arms

Experimental: Group 1 - Secukinumab 75 mg

Group 1 - Secukinumab (AIN457) 75 mg/0.5mL

Experimental: Group 2 - Secukinumab 150 mg

Group 2 - Secukinumab (AIN457) 150 mg/1.0mL

Interventions

Drug: - AIN457

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Portland, Oregon

Status

Recruiting

Address

Novartis Investigative Site

Portland, Oregon, 97232

International Sites

Novartis Investigative Site, Bruxelles, Belgium

Status

Recruiting

Address

Novartis Investigative Site

Bruxelles, , 1200

Novartis Investigative Site, Gent, Belgium

Status

Recruiting

Address

Novartis Investigative Site

Gent, , 9000

Novartis Investigative Site, Freiburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Freiburg, , 79106

Novartis Investigative Site, Hamburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Hamburg, , 22081

Novartis Investigative Site, Saint Augustin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Saint Augustin, , 53757

Novartis Investigative Site, Napoli, Italy

Status

Recruiting

Address

Novartis Investigative Site

Napoli, , 80131

Novartis Investigative Site, Krakow, Poland

Status

Recruiting

Address

Novartis Investigative Site

Krakow, , 31503

Novartis Investigative Site, Moscow, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Moscow, , 119991

Novartis Investigative Site, Saint-Petersburg, Russian Federation

Status

Active, not recruiting

Address

Novartis Investigative Site

Saint-Petersburg, , 194100

Novartis Investigative Site, Voronezh, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Voronezh, , 394036

Novartis Investigative Site, Yekaterinburg, Russian Federation

Status

Recruiting

Address

Novartis Investigative Site

Yekaterinburg, , 620149

Novartis Investigative Site, Santiago de Compostela, Galicia, Spain

Status

Recruiting

Address

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706

Novartis Investigative Site, Valencia, Spain

Status

Active, not recruiting

Address

Novartis Investigative Site

Valencia, , 46026

Novartis Investigative Site, Istanbul, TUR, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Istanbul, TUR, 34098

Novartis Investigative Site, Ankara, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Ankara, , 06100