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Completed

NCT Number: NCT00144573

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRA(Tocilizumab)

Drug

Primary outcomes

  1. 20% improvement based on the ACR criteria compared with the baseline value.

    Time frame: throughout study

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 5, 2005
Registry last updated
Dec 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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