An extension study of subcutaneous secukinumab in patients with Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10076674Term: Juvenile psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis; MedDRA version: 20.0Level: LLTClassification code 10072745Term: Enthesitis related arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2018-002521-30-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-08
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 63

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.

Other protocol-defined inclusion criteria apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 44
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Other protocol-defined exclusion criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term efficacy of secukinumab (provided as pre-filled syringes) with respect to JIA ACR30 response over time up to Week 308 in patients with active JPsA and ERA subtypes of JIA and who completed the Phase III study CAIN457F2304.;Secondary Objective: 1. To evaluate the long-term safety, tolerability and immunogenicity of secukinumab as assessed by vital signs, clinical laboratory variables and adverse events monitoring over time up to Week 308.<br>2. To evaluate the long-term effect of secukinumab treatment for all patients and each JIA category with respect to:<br>-JIA ACR/50/70/90/100 and inactive disease status<br>-Each JIA ACR core component<br>-Change from baseline of core study CAIN457F2304<br>-Juvenile Arthritis Disease Activity Score (JADAS)<br>-Total Enthesitis count<br>-Total Dactylitis count<br>3. To evaluate Pharmacokinetics (PK) of secukinumab.;Primary end point(s): JIA ACR30 response;Timepoint(s) of evaluation of this end point: Until Week 308 visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): AEs, lab values, vital signs, Anti-Drug Antibodies (ADAs).<br><br>JIA ACR 50/70/90/100, JIA ACR Core Components, Inactive Disease Status, JADAS Score, Total Enthesitis count, Total Dactylitis count.<br><br>Secukinumab serum concentrations and derived PK parameters.;Timepoint(s) of evaluation of this end point: Until Week 308 visit.