Long-term Treatment Study of MRA for Rheumatoid Arthritis... | NCT00144586

Studies
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

NCT00144586

Sponsor

Chugai Pharmaceutical

Status

Completed

Last Update Posted

Aug 9, 2013Estimated

Enrollment

42Actual

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

MRA(Tocilizumab)

Countries

Not provided

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

Aug 2013

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

Mar 2005

Primary Completion Date

Aug 2008Actual

Completion Date

Jun 2009Actual

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 2005Estimated

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

Aug 6, 2013

Last Update Posted Date

Aug 9, 2013Estimated

Description Module

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.

Detailed Description

Not provided

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

42Actual

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
20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.		throughout study

Secondary Outcomes

Measure	Description	Time Frame
Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.		Week 0, then every 4 Week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

RA patients who participated in the previous studies
Patients who completed the last observation in the previous studies
Patients who were confirmed to have no problems with safety in the previous studies.

Exclusion criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yuji Kimura	Chugai Pharmaceutical	Study Director

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

Intervention Browse Module

MeSH Terms

ID	Term
C502936	tocilizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided