Back to resultsClinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
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 who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria Patients with RA at least 6 months prior to enrollment Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min Exclusion criteria Patients with Class IV Steinbrocker functional impairment at enrollment Patients who are undergoing dialysis Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product
Sites / Locations
Outcomes
Primary Outcome Measures
20% improvement based on the ACR criteria compared with the baseline value.
Secondary Outcome Measures
Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.
Full Information
NCT ID
NCT00144573
First Posted
September 2, 2005
Last Updated
December 11, 2008
Sponsor
Chugai Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00144573
Brief Title
Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
Official Title
An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chugai Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.
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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MRA(Tocilizumab)
Primary Outcome Measure Information:
Title
20% improvement based on the ACR criteria compared with the baseline value.
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.
Time Frame
Week 0, Week 4
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
Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria
Patients with RA at least 6 months prior to enrollment
Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min
Exclusion criteria
Patients with Class IV Steinbrocker functional impairment at enrollment
Patients who are undergoing dialysis
Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product
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
Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
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