NCT00144560CompletedNot Applicable
An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Chugai Pharmaceutical
- Enrollment
- 31
- Primary Endpoint
- 20% improvement based on the ACR criteria compared with the baseline value.
Study Overview
Brief Summary
This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are diagnosed with RA according to the 1987 American College of Rheumatology (ACR) classification criteria
- •Patients who contracted RA at least 6 months prior
Exclusion Criteria
- •Patients with Class IV Steinbrocker functional impairment at enrollment.
- •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 initiation of treatment with the probe drug
Arms & Interventions
Untitled Study
Intervention: MRA(Tocilizumab) (Drug)
Outcomes
Primary Outcomes
20% improvement based on the ACR criteria compared with the baseline value.
Time Frame: throughout study
Secondary Outcomes
- Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.(Week 0,Week 1, Week 2)
Investigators
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