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CompletedNCT00144508Updated Feb 2, 2009

Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

A Phase 3 interventional study of MRA (Tocilizumab) and current treatment in Rheumatoid Arthritis, sponsored by Chugai Pharmaceutical. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2009-02-02.

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

Phase
Phase 3
Study type
Interventional
Enrollment
306
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.

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 306 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

  • Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987.
  • With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis.
  • Active RA despite at least one DMARD or immunosuppressant. Active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 2.0mg/dL.

Exclusion criteria

Exclusion criteria

  • Shown to have class-IV Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug.
  • Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug.
  • The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug.
  • Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
306 participants (actual)

Study arms

  • Experimental
    1

    Drug: MRA (Tocilizumab)

  • Other
    2

    continue current treatment

    Other: current treatment

Interventions

  • DrugMRA (Tocilizumab)

    8mg /kg /4week for 52 weeks

  • Othercurrent treatment

    continue current treatment

06

What researchers measure

Primary outcomes

  1. Change in the erosion score, as determined by the modified Sharp method.

    Time frame: week 52

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

    Time frame: throughout study

Secondary outcomes

  1. Change in the erosion score

    Time frame: week 28

  2. Changes in the joint space narrowing score and total Sharp score

    Time frame: week 28, 52

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 Feb 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00144508
Lead sponsor
Chugai Pharmaceutical
First posted
Sep 5, 2005
Start date
Mar 2003
Primary completion
May 2004
Completion
Feb 2006
Last update
Feb 2, 2009

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 Jan 2009. You cannot join it, but the record below documents what was studied.

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