NCT00144508

CompletedPhase 3

Phase III Comparative Study(Open-Label) of MRA for Rheumatoi...

Chugai Pharmaceutical Source

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Other study identifiers

Sponsor study identifier

MRA012JP

Study Type

interventional

Actual enrollment (reported)

306

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2004

Actual (reported)

Study Completion

February 2006

Actual (reported)

Brief Summary

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

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): 306 participants
Study completion date: February 2006
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 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
May 2004
Actual (reported)
First Submitted
September 2, 2005
Actual (reported)
First Posted
September 5, 2005
Actual (reported)
Study Completion
February 2006
Actual (reported)

Last Updated: February 2, 2009
Status Verified: January 2009
Last Update Submitted: January 30, 2009

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

Change in the erosion score, as determined by the modified Sharp method.
week 52
Frequency and severity of adverse events and adverse drug reactions
throughout study

Secondary Outcomes (2)

Change in the erosion score
week 28
Changes in the joint space narrowing score and total Sharp score
week 28, 52

Study Arms (2)

1

EXPERIMENTAL

Drug: MRA (Tocilizumab)

2

OTHER

continue current treatment

Other: current treatment

Interventions

MRA (Tocilizumab)Drug

8mg /kg /4week for 52 weeks

1

current treatmentOther

continue current treatment

2

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

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

Takahiro Kakehi
Chugai Pharmaceutical
STUDY DIRECTOR

Enrollment

306 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

March 2003

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

NCT00721123

A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With 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

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

NCT00750880

An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

Phase 3Completed

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.

You may not qualify if:

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.).

Contact the study team to confirm eligibility.

Primary Completion

May 2004

Actual (reported)

Study Completion

February 2006

Actual (reported)

Last Updated

February 2, 2009

Record last verified: 2009-01

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: NCT00144508
Data provider: ClinicalTrials.gov
Source updated: 2009-02-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:28 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

1

2

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