Study of MRA in Patients With Rheumatoid Arthritis (RA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
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 administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety. Patients confirmed to have shown the safety in the preceding study. Exclusion Criteria: Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug Patients who received any of the following treatments between the start of preceding study and the registration of this study. Plasma exchange therapy Surgical treatment (e.g., operation)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
ACR 20% responder rate compared to the pre-treatment in the preceding study
Frequency and severity of adverse events and adverse drug reactions
Secondary Outcome Measures
Time course of DAS28,compared to the pre-treatment in the preceding study
Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study
ACR N AUC compared to the pre-treatment in the preceding study
Time course of the ACR core set variables compared to the pre-treatment in the preceding study
Full Information
NCT ID
NCT00144651
First Posted
September 2, 2005
Last Updated
August 6, 2013
Sponsor
Chugai Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00144651
Brief Title
Study of MRA in Patients With Rheumatoid Arthritis (RA)
Official Title
An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
June 2009 (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 II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.
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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (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 for 1 year
Primary Outcome Measure Information:
Title
ACR 20% responder rate compared to the pre-treatment in the preceding study
Time Frame
throughout study
Title
Frequency and severity of adverse events and adverse drug reactions
Time Frame
week0,week4,week8,week12,and LOBS
Secondary Outcome Measure Information:
Title
Time course of DAS28,compared to the pre-treatment in the preceding study
Time Frame
week 0,week 4,week 8,week 12, LOBS
Title
Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study
Time Frame
week 0,week 4,week 8,week 12, LOBS
Title
ACR N AUC compared to the pre-treatment in the preceding study
Time Frame
week 0,week 4,week 8,week 12, LOBS
Title
Time course of the ACR core set variables compared to the pre-treatment in the preceding study
Time Frame
week 0,week 4,week 8,week 12, LOBS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
Patients confirmed to have shown the safety in the preceding study.
Exclusion Criteria:
Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
Patients who received any of the following treatments between the start of preceding study and the registration of this study.
Plasma exchange therapy
Surgical treatment (e.g., operation)
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
Study of MRA in Patients With Rheumatoid Arthritis (RA)
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