Secukinumab safety and efficacy in JPsA and 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: EUCTR2016-003761-26-BE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-16
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic arthritis (JPsA) according to the international League of Associations for Rheumatology (ILAR) classification criteria of at least 6 months duration.
2. Active disease (ERA or JPsA) defined as having both:
- at least 3 active joints
- at least 1 site of active enthesitis at baseline or documented by history.
3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs (NSAID)
4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
5. No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.

Other protocol-defined inclusion/exclusion criteria apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
2. Patients who have ever received biologic immunomodulating agents.
3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.

Other protocol-defined inclusion/exclusion criteria apply.

Study & Design

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