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Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

NCT ID: NCT00144573

Last Updated: 2008-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-10-31

Brief Summary

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This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MRA(Tocilizumab)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Chugai Pharmaceutical

Principal Investigators

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Takahiro Kakehi

Role: STUDY_DIRECTOR

Chugai Pharmaceutical

Other Identifiers

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MRA221JP

Identifier Type: -

Identifier Source: org_study_id