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

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Primary Purpose

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AIN457

About this trial

This is an interventional treatment trial for Juvenile Psoriatic Arthritis focused on measuring JIA, JPsA, ERA, Secukinumab, ILAR, Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis, cain457, cain457f

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1 - Secukinumab 75 mg

Group 2 - Secukinumab 150 mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with JIA ACR30 response

JIA ACR 30 is defined as 30% improvement from baseline in a minimum of three out of six variables with no more than one variable worsening more than 30% as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR 30 are: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Functional ability (CHAQ: Childhood Health Assessment Questionnaire) Number of joints with active arthritis Number of joint with limited range of motion Index of inflammation: C-reactive Protein (CRP)

Secondary Outcome Measures

Number of participants with JIA ACR 50/70/90/100 response

JIA ACR 50/70/90/100 are defined as 50%, 70%, 90% and 100% improvement from baseline respectively in a minimum of three out of six variables with no more than one variable worsening more than 50%, 70%, 90% and 100% respectively, as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR responses are: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Functional ability (CHAQ:" Childhood Health Assessment Questionnaire) Number of joints with active arthritis Number of joint with limited range of motion Index of inflammation: C-reactive Protein (CRP)

Number of participants with inactive disease status

In order for inactive disease to be confirmed in a patient when all the following conditions are met: No joints with active arthritis No uveitis CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA Physician's global assessment of disease activity score ≤ 10mm Duration of morning stiffness attributable to JIA lasting ≥15 minutes.

Number of participants with Juvenile Arthritis Disease Activity Score (JADAS)

JADAS will be derived from the following assessments: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Number of joints with active arthritis Tender and swollen joint counts Index of inflammation: C-reactive Protein (CRP)

Number of participants with total Enthesitis count

16 joints will be assessed for tenderness on each side of the body.

Number of participants with total Dactylitis count

The dactylitis count is the number of fingers and toes presenting with swelling and inflammation.

Pharmacokinetics (PK) of secukinumab

Concentration of secukinumab in the body

Full Information

NCT ID

NCT03769168

First Posted

November 21, 2018

Last Updated

September 18, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03769168

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 7, 2019 (Actual)

Primary Completion Date

October 3, 2024 (Anticipated)

Study Completion Date

November 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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).

Detailed Description

NOTE: Detailed Description : data not entered

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis

Keywords

JIA, JPsA, ERA, Secukinumab, ILAR, Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis, cain457, cain457f

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Open-label

Allocation

Non-Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 - Secukinumab 75 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2 - Secukinumab 150 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AIN457

Other Intervention Name(s)

Secukinumab

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with JIA ACR30 response

Description

JIA ACR 30 is defined as 30% improvement from baseline in a minimum of three out of six variables with no more than one variable worsening more than 30% as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR 30 are: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Functional ability (CHAQ: Childhood Health Assessment Questionnaire) Number of joints with active arthritis Number of joint with limited range of motion Index of inflammation: C-reactive Protein (CRP)

Time Frame

308 weeks

Secondary Outcome Measure Information:

Title

Number of participants with JIA ACR 50/70/90/100 response

Description

JIA ACR 50/70/90/100 are defined as 50%, 70%, 90% and 100% improvement from baseline respectively in a minimum of three out of six variables with no more than one variable worsening more than 50%, 70%, 90% and 100% respectively, as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR responses are: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Functional ability (CHAQ:" Childhood Health Assessment Questionnaire) Number of joints with active arthritis Number of joint with limited range of motion Index of inflammation: C-reactive Protein (CRP)

Time Frame

308 weeks

Title

Number of participants with inactive disease status

Description

In order for inactive disease to be confirmed in a patient when all the following conditions are met: No joints with active arthritis No uveitis CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA Physician's global assessment of disease activity score ≤ 10mm Duration of morning stiffness attributable to JIA lasting ≥15 minutes.

Time Frame

308 weeks

Title

Number of participants with Juvenile Arthritis Disease Activity Score (JADAS)

Description

JADAS will be derived from the following assessments: Physician global assessment of overall disease activity Parent's or patients' global assessment of patient's overall well-being Number of joints with active arthritis Tender and swollen joint counts Index of inflammation: C-reactive Protein (CRP)

Time Frame

308 weeks

Title

Number of participants with total Enthesitis count

Description

16 joints will be assessed for tenderness on each side of the body.

Time Frame

308 weeks

Title

Number of participants with total Dactylitis count

Description

The dactylitis count is the number of fingers and toes presenting with swelling and inflammation.

Time Frame

308 weeks

Title

Pharmacokinetics (PK) of secukinumab

Description

Concentration of secukinumab in the body

Time Frame

308 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97232

Country

United States

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Novartis Investigative Site

City

Saint Augustin

ZIP/Postal Code

53757

Country

Germany

Facility Name

Novartis Investigative Site

City

Genova

State/Province

GE

ZIP/Postal Code

16147

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31503

Country

Poland

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620149

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194100

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Voronezh

ZIP/Postal Code

394036

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Panorama

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

Halkali

ZIP/Postal Code

34303

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial