PhaseⅢOpen-Label Study of MRA for Rheumatoid Arthritis(RA) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 25, 2006

Last Updated Date

December 11, 2008

Start Date ^†

May 2006

Current Primary Outcome Measures ^†

Frequency of ACR 20％ improvement at the final visit [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Efficacy:
Frequency of ACR 20％ improvement at the final visit
Safety:
Frequecy and severe of adverse events and adverse drug reactions

Change History

Complete list of historical versions of study NCT00380601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Time course of the frequency of ACR 20％,　50％ and 70％ improvement,time course of individual items within the ACR core set. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Time course of DAS28 to the final visit. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Time course of steroid sparing effect from first visit to final visit. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

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

Descriptive Information

Brief Title ^†

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

Official Title ^†

An Open-Label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Brief Summary

An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Rheumatoid Arthritis

Intervention ^†

Drug: MRA(Tocilizumab)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

January 2009

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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
Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study

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 Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug
Subjected to any of the following within 4 weeks before administration of the study drug:
1. Surgical treatment (operations,etc.).
2. Plasma exchange method

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00380601

Responsible Party

Chugai Pharmaceutical Co.,Ltd., Chugai Pharmaceutical Co.,Ltd.

Secondary IDs ^††

Study Sponsor ^†

Chugai Pharmaceutical

Collaborators ^††

Investigators ^†

Study Director:

Yuji Kimura

Chugai Pharmaceutical Co., Ltd. Research Dept.1

Information Provided By

Chugai Pharmaceutical

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.