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Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

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Chugai Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Systemic Juvenile Idiopathic Arthritis

Treatments

Drug: placebo
Drug: MRA(Tocilizumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00144599
MRA316JP

Details and patient eligibility

About

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

Enrollment

56 patients

Sex

All

Ages

2 to 19 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)
  • Patients between 2 and 19 years of age
  • Patients who are under 16 years of age at onset
  • Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions

Exclusion criteria

  • Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product

  • Patients who have received the following treatments within 4 weeks before treatment with the investigational product

    1. Surgical treatment (e.g., operation)
    2. Plasma exchange therapy"

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

56 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: MRA(Tocilizumab)
2
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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