NCT00144547

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 MRA012JP.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Apr 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years 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

4.3 years

First QC Date

September 2, 2005

Last Update Submit

August 6, 2013

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)

    0W,4W,8W,12W,LOBS

  • Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria

    0W,4W,8W,12W,LOBS

Secondary Outcomes (2)

  • Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set

    0W,4W,8W,12W,LOBS

  • Frequency, severity, and seriousness of adverse events and adverse drug reactions

    Throughout study

Study Arms (1)

1

EXPERIMENTAL
Drug: MRA(Tocilizumab)

Interventions

MRA(Tocilizumab)DRUG

8mg/kg(i.v.)/4weeks

1

Eligibility Criteria

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

You may qualify if:

  • Patients must suffer from RA, and must have participated in the preceding study.
  • Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

You may not qualify if:

  • Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
  • Patients who have not been registered by 3 months after week 52 of the preceding 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

  • 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

April 1, 2004

Primary Completion

August 1, 2008

Study Completion

June 1, 2009

Last Updated

August 9, 2013

Record last verified: 2013-08