Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP
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 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.
Secondary Outcome Measures
Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.
Full Information
NCT ID
NCT00144586
First Posted
September 2, 2005
Last Updated
August 6, 2013
Sponsor
Chugai Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00144586
Brief Title
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP
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 MRA220JP or MRA221JP
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (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
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 MRA220JP or MRA221JP.
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
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MRA(Tocilizumab)
Intervention Description
8mg/kg/4 weeks
Primary Outcome Measure Information:
Title
20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.
Time Frame
Week 0, then every 4 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Kimura
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 MRA220JP or MRA221JP
We'll reach out to this number within 24 hrs