Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MRA(Tocilizumab)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion criteria Patients must suffer from RA, and must have participated in the preceding study. Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography. Exclusion criteria Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug Patients who have not been registered by 3 months after week 52 of the preceding study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)
Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria
Secondary Outcome Measures
Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
Frequency, severity, and seriousness of adverse events and adverse drug reactions
Full Information
NCT ID
NCT00144547
First Posted
September 2, 2005
Last Updated
August 6, 2013
Sponsor
Chugai Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00144547
Brief Title
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP
Official Title
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 MRA012JP
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chugai Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 MRA012JP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MRA(Tocilizumab)
Intervention Description
8mg/kg(i.v.)/4weeks
Primary Outcome Measure Information:
Title
Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)
Time Frame
0W,4W,8W,12W,LOBS
Title
Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria
Time Frame
0W,4W,8W,12W,LOBS
Secondary Outcome Measure Information:
Title
Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
Time Frame
0W,4W,8W,12W,LOBS
Title
Frequency, severity, and seriousness of adverse events and adverse drug reactions
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Patients must suffer from RA, and must have participated in the preceding study.
Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.
Exclusion criteria
Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
Patients who have not been registered by 3 months after week 52 of the preceding study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takahiro Kakehi
Organizational Affiliation
Chugai Pharmaceutical
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP
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