NCT00144586

Brief Summary

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_3 rheumatoid-arthritis

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

March 1, 2005

Completed
6 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
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

3.4 years

First QC Date

September 2, 2005

Last Update Submit

August 6, 2013

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.

    throughout study

Secondary Outcomes (1)

  • Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.

    Week 0, then every 4 Week

Study Arms (1)

1

EXPERIMENTAL
Drug: MRA(Tocilizumab)

Interventions

MRA(Tocilizumab)DRUG

8mg/kg/4 weeks

1

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • RA patients who participated in the previous studies
  • Patients who completed the last observation in the previous studies
  • Patients who were confirmed to have no problems with safety in the previous studies.

You may not qualify if:

  • Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product
  • Patients who were not enrolled by 3 months after the last observation day of the previous study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yuji Kimura

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2008

Study Completion

June 1, 2009

Last Updated

August 9, 2013

Record last verified: 2013-08