A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis

Phase 1

• Conditions: Systemic Juvenile Idiopathic Arthritis (sJIA); MedDRA version: 18.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-003490-26-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-20
• Study Completion: 2017-06-13
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 51

Inclusion Criteria

- Ages 1 (12 for patients in Russia) year up to and including 17 years at screening
- Diagnosis of systemic juvenile idiopathic arthritis
- Inadequate clinical response (in the opinion of the treating physician) to NSAIDs and corticosteroids
- Concurrent treatment with DMARDs (including methotrexate [MTX]), NSAIDs, and oral corticosteroids is permitted at the discretion of the investigator.
- Discontinuation of biologic agents (other than tocilizumab if the patient is receiving IV TCZ) for 4 days -20 weeks prior to baseline depending on biologic agent
- Female patients of childbearing potential and male patients with a female partner of childbearing potential must agree with the required contraceptive methods as defined per protocol.

Are the trial subjects under 18? yes
Number of subjects for this age range: 48
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

- Prior discontinuation of IV TCZ because of inadequate clinical response or safety events
- Patients with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
- sJIA that is well controlled by any treatment agent other than TCZ (JADAS-71) =3.8 with no fever)
- Patients who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA
- Prior stem cell transplant at any time

Study & Design

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