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CompletedNCT00144651Updated Aug 9, 2013

Study of MRA in Patients With Rheumatoid Arthritis (RA)

A Phase 2 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 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
135
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.

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 135 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 administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
  • Patients confirmed to have shown the safety in the preceding study.

Exclusion criteria

Exclusion Criteria:

  • Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
  • Patients who received any of the following treatments between the start of preceding study and the registration of this study.

    1. Plasma exchange therapy
    2. Surgical treatment (e.g., operation)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
135 participants (actual)

Study arms

  • Experimental
    1

    Drug: MRA(Tocilizumab)

Interventions

  • DrugMRA(Tocilizumab)

    8mg/kg/4 weeks for 1 year

06

What researchers measure

Primary outcomes

  1. ACR 20% responder rate compared to the pre-treatment in the preceding study

    Time frame: throughout study

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

    Time frame: week0,week4,week8,week12,and LOBS

Secondary outcomes

  1. Time course of DAS28,compared to the pre-treatment in the preceding study

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

  2. Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study

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

  3. ACR N AUC compared to the pre-treatment in the preceding study

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

  4. Time course of the ACR core set variables compared to the pre-treatment in the preceding study

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

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
NCT00144651
Lead sponsor
Chugai Pharmaceutical
Responsible party
Sponsor
First posted
Sep 5, 2005
Start date
Aug 2001
Primary completion
Jun 2009
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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