PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA) | NCT00380601

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

NCT00380601

Sponsor

Chugai Pharmaceutical

Status

Completed

Last Update Posted

Dec 23, 2009Estimated

Enrollment

20Estimated

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

MRA(Tocilizumab)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Aug 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Sep 25, 2006

First Submission Date that Met QC Criteria

Sep 25, 2006

First Posted Date

Sep 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2009

Last Update Posted Date

Dec 23, 2009Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
1	Experimental		Drug: MRA(Tocilizumab)

Name	Type	Description	Arm Group Labels	Other Names
MRA(Tocilizumab)	Drug	8mg/kg/4 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of ACR 20％ improvement at the final visit		throughout study

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yuji Kimura	Chugai Pharmaceutical Co., Ltd. Research Dept.1	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Chugoku region		Chugoku			Japan
Chukyo region

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided