NCT00144664

Brief Summary

This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

July 30, 2008

Status Verified

July 1, 2008

Enrollment Period

5 months

First QC Date

September 2, 2005

Last Update Submit

July 29, 2008

Conditions

Systemic Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (3)

  • Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS

    whole period

  • Safety:Incidence and severity of adverse events and adverse drug reactions

    whole period

  • Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration

    whole period

Secondary Outcomes (1)

  • Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS

    whole period

Study Arms (1)

1

EXPERIMENTAL

MRA(Tocilizumab)

Drug: MRA(Tocilizumab)

Interventions

MRA(Tocilizumab)DRUG
1

Eligibility Criteria

Age2 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)
  • Patients aged at least 2 years old and less than 20.
  • Patients aged less than 16 years old at time of onset

You may not qualify if:

  • Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product
  • Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Takahiro Kakehi

    Chugai Pharmaceutical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

November 1, 2004

Primary Completion

April 1, 2005

Study Completion

October 1, 2005

Last Updated

July 30, 2008

Record last verified: 2008-07