NCT00144625

Brief Summary

This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.

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 Feb 2005

Typical duration for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
2 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
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

5 months

First QC Date

September 2, 2005

Last Update Submit

December 21, 2009

Conditions

Polyarticular Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (3)

  • Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS

    every 3 months

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

    whole period

  • Pharmacokinetics:The time course of the trough values for the 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 variable of the JIA core set, CRP, pain every 3M, LOBS

    every 3 months

Study Arms (1)

1

EXPERIMENTAL
Drug: MRA(Tocilizumab)

Interventions

MRA(Tocilizumab)DRUG

8mg/kg/4weeks

1

Eligibility Criteria

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

You may qualify if:

  • Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
  • the patients who did not have problems with safety in the previous study"

You may not qualify if:

  • Patients who were not enrolled by 3 months after completion of the previous study
  • Patients who received any of the following since completion of the previous study until initiation of treatment in the present study
  • DMARDs or immunosuppressants
  • Intravenous and intramuscular injection of corticosteroids
  • Plasma exchange therapy
  • Other drugs and therapies that may affect evaluation of drug efficacy

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

February 1, 2005

Primary Completion

July 1, 2005

Study Completion

June 1, 2009

Last Updated

December 23, 2009

Record last verified: 2009-12