Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)

An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144560

Enrollment

Registered

2005-09-05

Start date

2005-02-28

Completion date

2005-08-31

Last updated

2008-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.

Interventions

DRUGMRA(Tocilizumab)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

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 1, Week 2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026