Rheumatoid Arthritis Clinical Trial
Official title:
An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA
Verified date | December 2008 |
Source | Chugai Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.
Status | Completed |
Enrollment | 31 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chugai Pharmaceutical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 20% improvement based on the ACR criteria compared with the baseline value. | throughout study | No | |
Secondary | 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 | No |
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