NCT00144586

CompletedPhase 3

Long-term Treatment Study of MRA for Rheumatoid Arthritis (R...

Chugai Pharmaceutical Source

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Other study identifiers

Sponsor study identifier

MRA222JP

Study Type

interventional

Actual enrollment (reported)

42

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2008

Actual (reported)

Study Completion

June 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 42 participants
Study completion date: June 2009
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 2, 2005
Actual (reported)
First Posted
September 5, 2005
Actual (reported)
Primary Completion
August 2008
Actual (reported)
Study Completion
June 2009
Actual (reported)

Last Updated: August 9, 2013
Status Verified: August 2013
Last Update Submitted: 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

Sponsors & Collaborators

Chugai Pharmaceutical
Industrylead

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

Enrollment

42 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

NCT00144521

Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

Phase 3Completed

NCT00144508

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

Phase 3Completed

NCT00106574

A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Phase 3Completed

NCT00144651

Study of MRA in Patients With Rheumatoid Arthritis (RA)

Phase 2Completed

NCT00144573

Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

Not ApplicableCompleted

NCT00144560

Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)

Not ApplicableCompleted

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.

Primary Completion

August 2008

Actual (reported)

Study Completion

June 2009

Actual (reported)

Last Updated

August 9, 2013

Record last verified: 2013-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00144586
Data provider: ClinicalTrials.gov
Source updated: 2013-08-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:46 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record