Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Chugai Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Systemic Juvenile Idiopathic Arthritis

Treatments

Drug: MRA(Tocilizumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00144612

MRA317JP

Details and patient eligibility

About

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Enrollment

60 patients

Sex

All

Ages

2 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria (MRA011JP patients)

Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period

Exclusion criteria

Patients who were not enrolled by 3 months after completion of the previous study
Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study