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

A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003490-26-DE

Enrollment

Registered

2013-06-05

Start date

2013-08-08

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponso

Eligibility

Sex/Gender

All

Inclusion criteria

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 non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids - Concurrent treatment with disease-modifying anti-rheumatic drugs (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

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 (Juvenile Arthritis Disease Activity Score (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

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Objective - To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with sJIA - To evaluate the pharmacodynamics of SC TCZ in patients with sJIA - To evaluate the safety of SC TCZ in patients with sJIA ;Secondary Objective: Not applicable;Primary end point(s): - Serum TCZ concentration and population PK model-predicted PK exposures area under the concentration-time curve (AUC) , maximum plasma concentration (Cmax ) and Cmin) for the initial QW and Q10D dosing regimens at steady state, and the Q2W dosing regimen at steady state in the <30 kg patients - Serum IL-6 and soluble IL-6R (sIL-6R) levels, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) - The incidence and severity of adverse events (including local injection-site reactions) and serious adverse events - The incidence and severity of adverse events of special interest - The incidence and severity of clinical laboratory abnormalities - The incidence of anti-TCZ antibodies ;Timepoint(s) of evaluation of this end point: - Pharmacokinetic endpoints will be evaluated at fixed timepoints during the first 14 weeks of the study [Weeks 0-14] - Pharmacodynamic endpoints will be evaluated at fixed timepoints during the first 14 weeks of the study [Weeks 0-14] - Adverse events, adverse events of special interest and clinical laboratory abnormalities will be recorded for the entire duration of the study [Weeks 0-52] - The presence of anti-TCZ antibodies will be evaluated at baseline and at regular intervals with event-driven testing in cases of anaphylaxis, serious hypersensitivity events, or any hypersensitivity event (including non-serious events) leading to treatment withdrawal (at the time of the event and at least 8 weeks after the event)	—

Measure

Time frame

Main Objective: Primary Objective - To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with sJIA - To evaluate the pharmacodynamics of SC TCZ in patients with sJIA - To evaluate the safety of SC TCZ in patients with sJIA ;Secondary Objective: Not applicable;Primary end point(s): - Serum TCZ concentration and population PK model-predicted PK exposures area under the concentration-time curve (AUC) , maximum plasma concentration (Cmax ) and Cmin) for the initial QW and Q10D dosing regimens at steady state, and the Q2W dosing regimen at steady state in the <30 kg patients - Serum IL-6 and soluble IL-6R (sIL-6R) levels, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) - The incidence and severity of adverse events (including local injection-site reactions) and serious adverse events - The incidence and severity of adverse events of special interest - The incidence and severity of clinical laboratory abnormalities - The incidence of anti-TCZ antibodies ;Timepoint(s) of evaluation of this end point: - Pharmacokinetic endpoints will be evaluated at fixed timepoints during the first 14 weeks of the study [Weeks 0-14] - Pharmacodynamic endpoints will be evaluated at fixed timepoints during the first 14 weeks of the study [Weeks 0-14] - Adverse events, adverse events of special interest and clinical laboratory abnormalities will be recorded for the entire duration of the study [Weeks 0-52] - The presence of anti-TCZ antibodies will be evaluated at baseline and at regular intervals with event-driven testing in cases of anaphylaxis, serious hypersensitivity events, or any hypersensitivity event (including non-serious events) leading to treatment withdrawal (at the time of the event and at least 8 weeks after the event)

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Argentina, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Russian Federation, Spain, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026