Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGMRA(Tocilizumab)
Sponsors
Chugai Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 20% improvement based on the ACR criteria compared with the baseline value. | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. | Week 0, Week 4 |
Outcome results
None listed