Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment - Full Text View

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

This study has been completed.

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144573

Purpose

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

Condition	Intervention
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)

MedlinePlus related topics:

Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Official Title:	An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [ Time Frame: Week 0, Week 4 ] [ Designated as safety issue: No ]

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144573

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators


Study Director:	Takahiro Kakehi	Chugai Pharmaceutical

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA221JP
First Received:	September 2, 2005
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00144573
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Autoimmune Diseases

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 31, 2008