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CompletedNCT00144547Updated Aug 9, 2013

Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

A Phase 3 interventional study of MRA(Tocilizumab) in Rheumatoid Arthritis, sponsored by Chugai Pharmaceutical. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-08-09.

Sponsored by Chugai Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
241
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 241 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Chugai Pharmaceutical is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
241 participants (actual)

Study arms

  • Experimental
    1

    Drug: MRA(Tocilizumab)

Interventions

  • DrugMRA(Tocilizumab)

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 0W,4W,8W,12W,LOBS

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

    Time frame: 0W,4W,8W,12W,LOBS

Secondary outcomes

  1. 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

    Time frame: 0W,4W,8W,12W,LOBS

  2. Frequency, severity, and seriousness of adverse events and adverse drug reactions

    Time frame: Throughout study

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00144547
Lead sponsor
Chugai Pharmaceutical
Responsible party
Sponsor
First posted
Sep 5, 2005
Start date
Apr 2004
Primary completion
Aug 2008
Completion
Jun 2009
Last update
Aug 9, 2013

Study contacts

Takahiro Kakehi
study director · Chugai Pharmaceutical

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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