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

Phase 1

• Conditions: 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; 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]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: A
• 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