Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Frequency of ACR 20％ improvement at the final visit
throughout study

Secondary Outcomes (3)

Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set.
throughout study
Time course of DAS28 to the final visit.
throughout study
Time course of steroid sparing effect from first visit to final visit.
throughout study

Study Arms (1)

1

EXPERIMENTAL

Drug: MRA(Tocilizumab)

Interventions

MRA(Tocilizumab)Drug

8mg/kg/4 weeks

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
Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL

Sponsors & Collaborators

Chugai Pharmaceutical
Industrylead

Study Sites (10)

Chugoku region

Chugoku, Japan

Chukyo region

Chukyo, Japan

Hokkaido region

Hokkaido, Japan

Hokuriku region

Hokuriku, Japan

Kansai region

Kansai, Japan

Kanto region

Kanto, Japan

Kousinetsu region

Kousinetsu, Japan

Kyushu region

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 Co., Ltd. Research Dept.1
STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 26, 2006

Study Start

May 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2008

Actual (reported)

PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

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 (3)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations